Saturday, May 26, 2018
Highlights

As per UNICEF and WHO estimates more than 2.4 million children in India below the age of five die due to improper sanitation. Gastroenteritis, dysentery, rota virus, cholera, hepatitis A and E, Typhoid  have been directly linked to lack of cleanliness and sanitation, while diseases like dengue, chikunguniya, and malaria etc which are due to insects are indirectly linked to sanitation. Encephalitis is another disease which has claimed around 25000 lives of children in the last forty years in India. In this year itself 114 deaths due to encephalitis have been reported in Gorakhpur in eastern Uttar Pradesh. The disease is caused by the bites of the Culex mosquito which breeds in filthy surroundings and poor sanitation.

In view of the above, it is imperative for India to adopt the Swachh Bharat Abhiyan and make it a success, to prevent further deterioration in sanitation, poor healthcare and further deaths of children.

Swachh Bharat abhiyan was launched on 2nd October 2014 by the Prime Minister, Shri. Narendra Modi as a national movement to achieve the vision of a Clean India by 2nd October 2019 as a tribute to Mahatma Gandhi, on his 150th birth anniversary.
Objectives of Swach Bharat Abhiyan

  1. Construction of Individual, cluster and community toilets.
  2. Elimination of Open Defecation
  3. 100% collection, scientific processing and disposal of waste.

Progress Report of Swachh Bharat Abhiyan
The Government in the latest progress report has claimed that total sanitation coverage has increased to 64.18 % up to July 2017, around 4.3 crore toilets have been built from a target of11.1 crore toilets by 2019, the states of Kerala, Sikkim, Himachal Pradesh, rural Haryana, and rural Uttarakhand have become Open defecation free (target of 100% ODF by 2019)

However, the program is lagging behind in providing clean drinking water to remote rural areas and   collection, processing and disposal of solid waste, which is very important for the success of the Swachh Bharat Abhiyan. Currently a handful of cities in the south have achieved 100% solid waste management, with Mysuru topping the list. Sadly the northern states are lagging behind in the implementation of collection, processing and disposal of solid waste management program. Reasons being non co operation and corruption inherent in the local municipal corporations and Health/Sanitation bodies, who stand to gain nothing by implementing the program. The public also do not seem to care enough to complain to the authorities about the disposal of garbage dumped on road corners and open spaces and restrict themselves to keeping their own houses clean. In many cities even segregation of waste is not being done and the work of collection of garbage has been outsourced to private contractors by the municipal corporations who even when given segregated waste by the residents mix everything into a single garbage collection bag and dump it into the roadside garbage bin.

If the Swachh Bharat Abhiyan has to succeed and meet its deadline of 02nd October 2019, it is high time the State Governments and the Centre start taking serious steps to implement segregation of waste, door to door collection of the segregated waste and final disposal by scientific processing on a war footing.

However, a permanent solution to a ‘Clean India’ can come about only when following steps are taken.

  1. Ban on manufacture of plastic bags
  2. Ban on manufacture of all forms of tobacco products
  3. Banning and closing down all industries which flush their effluents into the rivers, canals and drains.
  4. Implement and make stricter laws with penalties against littering, spitting, and defecating in public places.

S.G.B.Rao

LSW Lifescienceworld

Corporate world has seen many mergers and acquisitions, privatization, nationalization of companies and closures of the glorious ones. But turning a company making loss for more than 60 years into a profit making one within two financial years is applause worthy.

Here is a classic example of Bengal Chemicals & Pharmaceuticals Ltd – India’s very first pharma company that changed the dynamics of the corporate world.

This remarkable turnaround has taken place under the leadership of P M Chandraiah, a remarkable person himself, who started his career as a humble Typist-cum-Office boy with a leading organization’s showroom and now Managing Director of Bengal Chemicals & Pharmaceuticals Ltd whose achievement is highly applauded. (Read: The Man behind Bengal Chemical’s Turnaround)

Acharya Prafulla Chandra Ray Founder, Bengal Chemicals (1861-1944)
Acharya Prafulla Chandra Ray
Founder, Bengal Chemicals (1861-1944)

Bengal Chemicals & Pharmaceuticals Works (BCPW) was formed in 1901 with a meager capital of Rs. 700 by Acharya Prafulla Chandra Ray, an academician and scientist.

He obtained B. Sc and D. Sc from Edinburg University on a scholarship and started his career as Assistant Professor of Chemistry in Presidency College, Kolkata.

He can rightly be referred as the Father of Indian Pharmaceutical Industry. The company produced various products of British Pharmacopoeia standard and also brought out the country’s first anti snake venom drug.

BCPL’s Maniktal Factory Gate
BCPL’s Maniktala Factory Gate

Factory at Panihati, North 24 Paragans district
Factory at Panihati, North 24 Paragans district

Soon BCPW became the first Indian Company of its kind to manufacture quality Chemicals, Drugs, Pharmaceuticals and Home Products, employing indigenous technology, skill and raw materials for production of quality Drugs & Pharmaceuticals and Chemicals with indigenous technology to cater the needs of millions of common people, foster growth of Indian Industries, compete with imported goods and to become self-sufficient.

Bengal Chemicals struck a note famously for their household products, namely, Cantharidine Hair Oil, Aqua Ptychotis, Phenyl, Klin Toilet cleaners and naphthalene ball.

Cantharidine Hair Oil
P M Chandraiah, Managing Director
P M Chandraiah, Managing Director

As part of financial restructure, Chandraiah initiated a centralized system for all financial activities like Procurement, Accounting, Sales Collection, Payment, Bill Processing, Payroll, Stores System etc, which yielded in reduction of procurement costs and stopped financial leakages in the company.

According to Chandraiah, “First time in the history of the company, BCPL has reported a Net Profit of Rs.4.51 Cr. in 2016-17 against a Net Loss of Rs.37 Cr. reported in 2013-14.  Further, Company has reported a Gross Margin of Rs.24 Cr. in 2016-17 against a Gross Loss of Rs.20 Cr. reported in 2013-14.

Recent Sales Chart showing increased profits:

Particulars 2013-14 2016-17 % increase
Pharmaceuticals 5.49 54.09 985%
Home Products 9.97 26.28 264%
Industrial Chemicals 1.60 5.00 313%
Total 17.06 85.37

 

BCPL’s Home products like Cantharidine Hair Oil, Phenyl, Naphthalene balls which were once a household name, are being revived and as part of e-commerce marketing, the company has already tied-up with Bigbasket to sell the products.

Due to the improvement in Financial Discipline and improvement in transparency, first time in the history of the Company, BCPL has been awarded EXCELLENT MoU Rating for the year 2015-16 and also got EXCELLENT Corporate Governance Rating for the 2015-16 as well in 2016-17 by Dept. of Public Enterprises, Govt. of India.

antibiotics-highlights

What are Antibiotics

Antibiotics are powerful medicines that can stop bacteria from reproducing or destroy them. An antibiotic is given for the treatment of an infection caused by bacteria. Antibiotics cannot be given for diseases caused by VIRUSES like the common cold or sore throat. It is used to prevent infections also, in case of surgeries, e.g.: bowel and orthopaedic surgeries.

Common and rare side effects of antibiotics

Common side effects are diorehea, fungal infections of the mouth, digestive tract and vagina etc.

Rare side effects are formation of kidney stones (due to taking sulphonamides), abnormal blood clotting (cephalosporin), sensitivity to sunlight (tetracycline), blood disorders (trimetroprism), and deafness (erythromycin)

Antibiotics should be used with extreme caution in patients with reduced liver/kidney functions, pregnant women and breast feeding women.

What is antibiotic resistance

Antibiotics drugs if given more often make the bacteria mutate to make the drugs given to kill/destroy them ineffective. Overusing and taking them in incorrect doses magnifies the problem and creates super bugs which kill the good bacteria in the body and weakens the immune system, as a result diseases like gonorrhoea and strains of tuberculosis which were earlier curable have now become incurable. Due to the weakened immune system, more people get sick and stay sick longer. It is alarming to note that when antibiotics stop working, procedures like C sections, hip /knee operations and chemotherapy will become dangerous. Organ transplants will become impossible to survive.

India has been the World’s highest consumer of antibiotics followed by China and as a result is threatened by the super bugs which make antibiotics ineffective and the majority of hospitals in India including the prestigious All India Institute of Medical Sciences (AIIMS), have 4 out of every 10 patients in ICU, with drug resistant bacteria which makes recovery difficult and increases the mortality risk.

The death of an American woman due to a superbug likely contracted while undergoing treatment of thigh bone fracture in India has triggered the Drugs Controller General of India to issue directives to the pharma supply chain, including retailers, chemists and drug manufacturers to strictly follow norms while selling antibiotics.

The State drug regulators also have been directed to take strong policy measures and strict regulatory action on over the counter (OTC) sale of antibiotic drugs. To check indiscriminate use of high end antibiotic drugs, the Govt have already introduced a red line on the strips to differentiate from other drugs. This move was aimed at discouraging OTC sale of antibiotic drugs and its indiscriminate use for all diseases leading to ‘antibiotic drug resistance’. Experts blame poor public Health systems, hospital infection, high rates of infectious diseases and pollution for the prevalence of the super bugs (antibiotic resistant bacteria) in India.

How to stop Antibiotic Resistance

Marc Sprenger, Director of WHO’s Secretariat for anti microbial resistance, has given the following prescription to stop the growing menace of antibiotic resistance and the super bug.

  1. Doctors, nurses, Chemists and other health workers should stop prescribing /dispensing antibiotics unless they are absolutely necessary for the patient’s disease.
  2. People using healthcare (i.e., you and me) should take antibiotics only when prescribed by a certified health professional and only after enquiring that you really need them. Always complete the full prescription even if you feel better, because stopping treatment early promotes the growth of drug resistant bacteria.
  3. Farmers and others in agriculture sector should ensure that antibiotics are given to animals only to control or treat infectious diseases. Misuse of antibiotics in livestock, aquaculture and crops is a key factor contributing to antibiotic resistance and its spread into the environment, food chain and humans. Clean and un-crowded conditions and vaccination of animals can reduce the need to use antibiotics.

 

S G B Rao, LSW Lifescienceworld

air-pollution-lswA WHO study of 1600 cities across the World has revealed that Delhi is the World’s worst city for air pollution.

The main causes of air pollution in Delhi and NCR identified by the National Green Tribunal (NGT) are :-

* burning of plastic and other wastes including agriculture/horticulture waste in the open.

* pollution resulting from construction and other allied activities.

* pollution resulting from vehicular traffic and industrial pollution.

However, the biggest culprit is vehicular traffic and car ownership.

Delhi alone has more than 7.5 million registered vehicles and more than 1500 personal vehicles being added everyday in Delhi alone of which, more than 50% are diesel vehicles.

More than 80,000 trucks run on diesel travel through Delhi between 8 pm and 6am every night on their way to other cities in the north, west, east and south  contributing  to 60% of the air pollution in Delhi.

After the National Green Tribunal’s (NGT) orders to the Delhi and the Union Governments to take immediate steps to control air pollution in Delhi and NCR, the Ministry of Environment has set a three month deadline for controlling pollution in Delhi/NCR by taking following steps :-

  • Banning polluting vehicles from entering Delhi by strict checking
  • Imposing cess on trucks only passing through Delhi to avoid toll otherwise payable on highways by passing Delhi
  • Banning 10 year old diesel vehicles
  • Turning coal fired electricity producing plants to gas plants
  • Banning burning of leaves and grass by making it illegal
  • Amend the motor vehicles Act
  • Train sanitation workers to comply with environmental rules and implement them

 

The Delhi Government also proposes to implement Lt. Governor Najeeb Jung’s high powered committee’s action plan as below:-

  • Rupees one cess to be imposed on purchase of every pack of cigarettes and each bottle of liquor to create a Urban Transport fund to fight pollution
  • Traffic police to make PUC (pollution under control certificate) stickers mandatory for buying petrol/diesel
  • Entry of non-destined vehicles to Delhi to be regulated and cess to be imposed
  • New parking policy to be implemented, where parking fees to be revised
  • Battery operated vehicles for last mile connectivity and DMRC (Delhi Metro) to introduce 8 coach rakes before 2017

All the above steps once implemented by the Government will go a long way in controlling air pollution in Delhi but these are not a permanent solution to the problem until they stop registering new cars and trucks that too diesel powered. With more than 1500 new vehicles being registered every day in Delhi alone, the traffic on the roads will put tremendous pressure on the existing roads and no amount of widening of the roads or constructing new roads and flyovers will solve the problems of traffic jams and pollution.

Some recent steps taken by the Delhi Government to bring down pollution levels immediately like the much touted Odd/Even scheme was a complete failure. It only compounded the harassment caused to all sections of the society with its exemptions and encouraged honest citizens to resort to cheat by using fake CNG stickers or using fake registration plates for both odd and even days. Further there was no appreciable decrease in pollution levels, though a large decrease in traffic congestion and commuting time was seen which brings home the fact that the Delhi roads cannot handle the volume of vehicles on it. Thankfully the odd/even scheme is only a temporary measure and the citizens of Delhi/NCR hope they will not have to go through any more odd/even days.

The Government would do well to take some long standing measures as follows immediately:-

*stop registering new diesel vehicles

* encourage manufacture of vehicles run on green fuels like electricity, CNG etc by heavily subsidising them so that they are cheaper than diesel and petrol powered vehicles allowing existing owners of polluting vehicles to switch over to these environmental friendly vehicles

* convert one lane along all major roads into bicycle tracks with fencing to prevent motorised vehicles encroaching into bicycle tracks.

*strict implementation of lane driving culture by creating separate lanes for heavy vehicles, cars and motorised two wheelers

*good maintenance of roads and traffic signals

However, controlling pollution is not the responsibility of the Government alone but also the responsibility of every citizen of Delhi/NCR and each and every citizen can contribute to the efforts to control pollution by doing the following :-

  • Avoid the car where you can walk, take a public transport like the Metro where available
  • Follow traffic and road safety rules voluntarily without waiting to be told by the policeman
  • Keep a constant check on your vehicle to see that it is non polluting

If all the above measures are implemented sincerely, there is no reason why the pollution levels cannot be brought down and Delhi will once again be the green city it once was.

 

S.G.B.Rao

LSW LifeScienceWorld

Vitro evaluation specialist in sun screen products entering India

HelioScreen, a French company involved in evaluation of sun protection products has entered Indian market partnering with C.L.A.I.M.S  Pvt Ltd, a Mumbai based CRO specializing in clinical research in the area of skin, hair and body care.
15 year old Helioscreen is a laboratory providing services for testing any products (cosmetics, textile, clothes etc.) in regard of their properties for UV /sun protection by means of In Vitro testing. With their profound involvement in R&D, and conceptualized a very particular kind of ‘robot’ which is considered as a performer in UV protection as it ensures consistency during In Vitro testing.

LSW met Dr. Dominique Lutz, CEO and found out more about sunscreen technology and his company HelioScreen.

Excerpts from the interview conducted during his visit to Mumbai.

Dr. Dominique Lutz CEO, Helioscreen
Dr. Dominique Lutz
CEO, Helioscreen

LSW : In general, some of the sunscreen agents which are in use are uncertain on safety and efficacy. What are your views on this?

Dr. Dominique Lutz : As long I know and considering the most important companies, we cannot state some ingredients are uncertain on safety. I know some debates on some of them but it is not a tremendous problem. Clearly the industries have to comply with the quality of these ingredients. The same filter (i.e. bmdbm now out of its patent) can be produced on bad conditions and include by product. But this is another story. Now considering the purpose of product including sun filters, I would totally agree we can state some products are uncertain on safety if we mean the safety is to protect the consumer from harmful UV exposure, some time it may be better not to be protected than protected by a “bad” product. And a so called bad product may be a product which claims a high SPF protection only in the UVB range. This has been the starting point to define a new way of protection including UVB and UVA and balanced effect on the all spectrum. It is far from being followed and even check with testing in some companies.

LSW: Claims of water-proof, instant protection etc are misguiding users particularly when it comes to cosmetics. Your comment.

Dr. Lutz : I totally agree even if cosmetics are efficient this is a pity that the marketing claims, lead the customer to be misguided for its use or the benefits he can expect from the product sometimes it may also be dangerous and claims must be controlled with attention by the authorities. As an example claim of full UV screen may induce customer not to pay attention with an over exposure. Sometimes it could be helpful and efficient to explain to the consumers as an example a product needs to be spread long before exposing and more efficient if renewed frequently in order to make it to perform “normally”. There is a chemical process and it is not enough just to spread the product at the last moment. May be the marketing should be first informed to give the good advice.

LSW : Many sun screening products are available in India, but the composition details are not clear because most of them are cosmetic products. How do you propose to go about this in your foray in the Indian market?

Dr. Lutz : : I think the rules in EU or other countries to exhibit CTFA formula is something logical. It is not so complicated to put in place but I think India health authorities have a lot to do to go towards international standard for claiming, demonstrating, testing etc…

LSW :Unlike the US FDA and EU guidelines, in India there are no set guidelines for standardization. Some of the agents are manufactures by pharmaceuticals companies as combination products like cosmetics. Will you be focusing only on cosmetic area pertaining to skin, hair and body care?

Dr. Lutz : Most of the time yes because they are these rules and guideline which are compulsory and so plenty of requirement to market a product. Nevertheless ourknow about is to measure the UV transmission (or no UV transmission) and we have had plenty of different works done on specific material. Just let me take as example textile, Sun glasses or even plaster. Let me also precise the countries in which we have the most important market are not automatically the ones in which they are the rules. In that case there is a hard competition and sometimes customers just care about the report and not the quality of the information. In Vitro AND in vivo tests can be really variable, any one would agree with this statement. At the same time, industrials or laboratories when developing need some tools to be efficient. It is not with your expertise, long experience you can guarantee a results even choosing the best ingredients. Only some specific tests most of the time different from the ones for claiming are the tolls to ensure and potentialize the results.

LSW : Generally, sun screens are available in the cream. Lotion, sprays which are OTC (over the counter) products. Are you planning to look into pharmacokinetics area?

Dr. Lutz : We already work with pharmaceutical companies in France. When a product needs a certification to be classified as a medicine, plenty of tests which have nothing to see with the claiming tests are required by the authorities. Also we did some method on photo stability for the Canadian health authorities etc…Clearly it also depends on the rules of each country.

LSW : Now that HelioScreen is entering the Indian market, with a focus on personal care products which is a competitive market. Do you plan to look at offering your solutions to other areas also?

Dr. Lutz :Considering the testing for UV protection efficiency there is so much to do and in fact no yet competitors, we prefer to be concentrated that allow us to be really a specialist as required for such a task.

LSW : you share some information on HelioScreen’s partnership with C.L.A.M.S

Dr. Lutz : We have had plenty of proposals from India but CLAIMS is doing the same job means TESTING and they have the serious and organization to propose complementary tests they cannot perform themselves. They have the background to explain the technique and it is not only a business opportunity but a real partnership.

LSW : Finally, a brief history of your company and the future plans in India in particular.

Dr. Lutz : Helioscreen has been created 15 Y ago with the only aim to propose in vitro testing services for sun screen evaluation. But at that time in EU, there were no methods, no market, and no trust in these services. Just my conviction it will be the future with my experience within COLIPA and a solid relationship with French Industries. Also the opportunity when I quit the industry to became an independent expert nearby French Health authorities and the possibility to work and contribute a lot both on a technical point of view and also political in EU Commission. Afterwards we have been logically involved in the ISO worldwide process as expert.

My company has become more important and now has competitors but we have proposed the most important innovations in the development of these methods and will stay forever the forerunner. Today our contribution in RD in very huge compared to the size of my company. Also the development all over the word as these methods must be applied all over the word to be efficient. We can take for sure the future SPF standard on which we are working for decades in the international committee will have been proposed from our laboratory.

LSW : Any other information that you would like to share with.

Dr. Lutz : Unless in a country where there is still few constraint to put a product on the market the new requirement for sun protection claiming are more and more understood by consumers. Also keeping with the technical requirements about protection ( UVB/UVA) is not so easy, so it is better to be ready for the very next future of the legislation and requirement from consumers than wait for compulsory rules from authorities. That will make the difference.

Lawrence & Mayo, Mumbai
Lawrence & Mayo, Mumbai
Vision/Eye problems are caused due to various conditions. Some are as follows:

Presbyopia, Cataracts, Diabetes, Macular degeneration, Eye Infection, Inflammation, Injury,
Floaters, Night Blindness, Retinal detachment, Optic Neuritis, Stroke, Migraine Headaches.

All these above mentioned problems if not treated in the initial stages or ignored, may lead to blindness.

Added to these, what causes eye/vision problems occurring to most, irrespective of age, is Computer Vision Syndrome.(CVS )

CVS doesn’t cause permanent damage to your eyes, but it can be a major cause of discomfort, fatigue, and loss of productivity. The American Optometric Association defines CVS as an eye and vision-related problem due to working for long hours on the computer gazing at the computer screen.

Some common symptoms typically fall into three categories: vision problems, eye problems, and general discomfort.

According to Better Health Channel, a health channel funded by State government of Victoria, the illuminated computer screen can also cause eye fatigue. Use of laptops has caused more pains, strains and injuries to eyes.

Eye care has evolved from age-related vision disorders to cosmetic concerns. Spectacles are nowadays considered as personality enhancers and a fashion accessory.
Eyewear as a sector in India is fast growing. Ever growing presence of high end products, changing lifestyles, opting for foreign branded sunglasses, lenses and frames have attributed to lot of branded optical companies and leading corporate houses setting up eyewear companies and shops having developed into an industry itself.
However, among various eyewear companies in India, the name that strikes first is the more than a century old Lawrence & Mayo.

The Optical and Instruments business of Lawrence and Mayo, traces its roots to two London based Jewish families, that of Lawrence and Mayo who by tradition were jewelers and watchmakers.

The two families set up operations all over the world.  First in London, then in Calcutta, Bombay, Karachi, Rangoon (Burma), Colombo and then in Cairo, Spain, Portugal, and Singapore. Its reputation as a chain of high-grade opticians and makers of the best quality survey, scientific and meteorological instruments was well known.

Lawrence & Mayo, London
Lawrence & Mayo, London

Lawrence and Mayo set up its establishment in India in 1877 by opening its showrooms in Calcutta and Bombay. Later in 1938, under Indian Companies Act of 1913, L & M was incorporated as a private limited company under the leadership of a Britisher named L H Aliston.

During this period, there was an Indian by name I C Mendonca working with the company, who was instrumental in expansion of the company’s activities by setting up an optical workshop and showrooms in Karachi and Lahore. He returned to Calcutta before the partition and continued with the operations of the company.

I C Mendonca
I C Mendonca

In 1959, I C Mendonca took charge as Managing Director of L&M and laid the foundation for the future role in India. In 1967, he bought over the entire shares of the company turned Lawrence and Mayo as a fully Indian company and the journey continued. Today, his sons and grandchildren are involved in the running of the establishment dividing the responsibilities among themselves and taking the vision and mission of the founders to further heights.Today, his sons and grandchildren are involved in the running of the establishment dividing the responsibilities among themselves and taking the vision and mission of the founders to further heights.

From left to right: Mr M Mendonça, Mr R H Mendonça & Mr J Mendonça
From left to right:
Mr M Mendonça, Mr R H Mendonça &
Mr J Mendonça

His eldest son R H Mendonca is the Chairman & Managing Director, and other two sons J Mendonca and M Mendonca are assigned as Technical Director and Finance Director respectively.

These elders are supported by their respective children by running the day to day affairs of the company.

Lawrence & Mayo is also actively involved in educational field promoting Optometry – an academic course (degree and diploma) which has least awareness due to lack of institutes and colleges involved in this subject. Vivek Mendonca, the grandson of I C Mendonca who is also the marketing Director of Lawrence & Mayo is also the President of ASCO-India (Association of schools and colleges of Optometry in India) which is formed to promote Optometry as an academic course.

The 3rd Generation Management team. From Left to Right: Menaka Mendonca (Process & IT), Amitava Mendonca (Marketing & Operations Head for South - East) Vivek Nandodkar (Sales, Technical n Purchase), Michelle Nandodkar (Finance, Purchase - Opticals, Human Resources), Vivek Mendonsa (Marketing - North, West & Karnataka), Suzanne Poncha (Professional Services) Bachelor of Optometry ,City University, United Kingdom ,England, Rajiv Nandodkar (4th Generation) (Digital & On- Line Marketing, In-store Marketing), Geetanjali D'Souza (Finance, Human Resources - South East)
The 3rd Generation Management team.
From Left to Right: Menaka Mendonca (Process & IT), Amitava Mendonca (Marketing & Operations Head for South – East) Vivek Nandodkar (Sales, Technical n Purchase), Michelle Nandodkar (Finance, Purchase – Opticals, Human Resources), Vivek Mendonsa (Marketing – North, West & Karnataka), Suzanne Poncha (Professional Services) Bachelor of Optometry ,City University, United Kingdom ,England, Rajiv Nandodkar (4th Generation) (Digital & On- Line Marketing, In-store Marketing), Geetanjali D’Souza (Finance, Human Resources – South East)

LSW LifeScienceWorld gathered more information on Lawrence & Mayo from Vivek Mendonsa, Marketing Director and grandson of I C Mendonca

Vivek Mendonca
Vivek Mendonca

LSW:  Is it appropriate to say that Lawrence & Mayo is India’s pioneering and leading optical branded store with more than 90 branches throughout India?
Vivek Mendonsa: Yes, it will be appropriate as we are a Store Brand having more than 450 Brands with us and our Private Label of Frames, Sunglasses, and LM Watches & LM Pens.

LSW:  Do you have your own manufacturing unit for optical glasses and lenses?
VM:  We have our own Processing Unit where we process raw glass blanks and plastic (CR-39 Blanks) into Spectacle Lenses .We also have 15 Edging & Fitting units across the Country.

LSW: Fiber and plastic lenses are widely manufactured and marketed. How good are these compared to the traditional optical glasses?
VM:  Glass is the first material made out of boric silicate (found in sand), there has been several experiments with resins (plastics) and after Columbia Resin failed 38 times, finally producing it for the 39th time, it has become the industry norm. Glass is Conventional and can break. It is heavier and thicker.
CR- 39 (Plastic) is Lighter, Thick, doesn’t easily break, can shatter, and develop scratches with rough use Polycarbonate is Lighter, Flatter, most expensive out of the three, shatter proof, has in- built UV Protection.
Today Lenses come with Dirt Resistance, Water Repelling Properties, and Thumb Impression Resistance.

LSW: Spectacles or lenses are better worn after proper eye test. Trendy frames are being introduced and contact lenses are sought after as a fashion accessory. Your views.
VM:  Spectacles have become a style statement; people wear them even if they don’t have power .The Hindi movies have made them popular; there is not a single movie being released without the Hero, Heroine, Actor & Actress donning Spectacle Frames and Sunglasses.
Contact Lenses are gaining popularity with science & technology with higher water content up to 66 % of water as our body is made up of water .Thinner lenses ,made such that the eye ,the most sensitive organ will not treat it as a foreign body .The Best Brands like Alcon ,Bausch & Lomb & Johnson & Johnson are available .

LSW: Some information on the spectacle frame market.
VM:  Every 2 weeks a new model Frame is launched under an existing Brand, be it a new Color, two tone colors, new material, fashion & style keeps coming in and going out, trimmings to appear & disappear.
We have NIFT –National Institute of Fashion & Technology & NID – National Institute of Design. Though we are manufacturing lot of Frames in India, particularly in Gujarat, we need strong Indian Brands which are exported.
We have Safilo & Luxottica, the World’s largest Giants in India.
There are many European handmade Frames & Brands that are slowly trying to come to India & Asian market.

LSW:   Are contact lenses having an edge over spectacles?
VM:  Contact Lenses are worn by those who prefer to express themselves in only Contact Lenses, they switch between Contact Lenses and Spectacle Frames .These could be teachers, news readers, actors & actresses, Trainers, Showmen & Show women.

LSW:  Normally, it was a practice getting eyes checked by an ophthalmologist.  Now every other optical shop carries out eye test and suggests lenses.  Is this a right way?
VM:  Ophthalmologist is Surgeon and trained to do Operations for the internal parts of the Eye .They are MMBS, MS- Master of Surgery .Eye-Test and Vision Screening is not their primary task.
Most Senior Ophthalmologist has 3-6 Optometrists working under them to do all the work –up until they are ready to meet the Ophthalmologist.
At Lawrence & Mayo we have our 10 Point Precision Eye –Test (PET), which is executed by Lawrence & Mayo’s Qualified, Trained & Experienced Optometrist.

LSW:  When it comes to reading glasses, there are ready-to-use glasses available in specific optical power.  Are these advisable?
VM: Ready Readers are available at various purchase points like outside Railway Stations ,Footpath, stationary shops .The Quality of these could be suspect as ‘cheap ,never means Quality’ . They come in steps of 0.25 Diapers.
We produce our own L&M Ready Readers in our workshops and factories.

LSW:   How different is Lawrence & Mayo from others?
VM: There are 35,000 Optical Stores in India, from A Grade to G Grade .Selling all kinds of products, sourced from all over India & abroad, known & unknown Brands .Or their own Brands.
We source and use only the A Grade material in our company to produce the finest lenses and Spectacle Frames, Sunglasses and Contact Lenses.
India’s standing on the manufacturing front with regards to optical glasses and lenses.
India had one glass manufacturing unit in Durgapur, which has been shut for long time, Government of India must focus on Policy & Decision making. Running of factories, providing services must be in the Private Sectors Hands.

LSW:  On the current status of eyewear market and Lawrence & Mayo’s share in the branded store segment and growth plans.
VM:    Lawrence & Mayo has 95 Stores in 38 Cities of India; we would definitely be having a high percentage of market share in the premium eye wear & sun wear market.

LSW:  You are a pioneer in scientific and industrial instrumentation as well. Some information on your product range and the core industry/sector you are catering to.
VM:We have a strong Engineering, Scientific, Vacuum, Vocational Range of products with over 1,500 Engineering Products, 85 Different types of Microscopes. Thirty Nine engineers to install commission and give back up and after sales support. We have 15 International partnerships in this sphere.

LSW:  Microscopes are another area of your activity. Some inputs.
VM:  Microscopes are used in pathology ,dental ,bio-technology ,teaching ,metallurgy etc .We have a dedicated team and each year we are doing thousands of commissioning of Microscopes in all Research Labs across the Country .

LSW:   As part of expansion, Lawrence & Mayo is also into accessories, dealing in pens and watches. Are you into distributorship of leading global brands or any specific marketing deal whereby you are selling under LM brand?
VM:  Lawrence & Mayo has defined itself in Healthcare, Optics & Optoelectronics, Measurement of Distance, Air, Water, Temperature, Measurement of Time (Watches & Clocks) all L&M Brands, Environment Products – dealing with agriculture and Green Houses.
This could be abbreviated to the word ‘HOME’

LSW: What is the impact of laser surgery which has now become a fad on the conventional correction of eye sight with spectacles and contact lenses?
VM:Laser Refraction has been around for last 30 years .Every 3-5 years it comes up with better technology. There is a growing audience opting for it. The cost factor is Rs. 20,000/- (Twenty thousand) per Eye up to Rs. 40,000/- (Forty thousand per Eye) depending on the Doctor & Patients’ paying capacity.
After the age of 40, people are tend to get a small prescription & return to reading glasses.
India being a price sensitive market, few cities are seeing a surge but it is not a mass exodus. With reading and lifestyle habits, constantly on the phone –watching texting (sms) has added to huge numbers of people with Eye problems.

LSW:   L&M’s future plans.
VM:  Lawrence & Mayo will continue to grow from strength to strength, at some stages consolidating in certain markets and spheres, in others growing and expanding .It is strong & robust company with a HUGE Brand Equity.
Whatever Lawrence & Mayo does, it does it with style, passion, finesse, Quality and in an Ethical Manner.

Lawrence & Mayo – Chronology
~ 1877
Queen Victoria proclaimed herself as the Empress of India at the Delhi Durbar. A few hundred miles away, another entity was staking its claim to a different dimension of power. An entity that would strive to give India vision and precision, this entity was Lawrence & Mayo (L&M), a two-divisional company that focused on Ophthalmic Optics and Scientific Instrumentation. It made its debut with showrooms in Calcutta (now Kolkata) and Bombay (now Mumbai). Another interesting that took place – world’s very first Cricket Test was played between England and Australia marking the beginning of the Ashes Rivalry.
~ 1892
His Excellency General Sir Frederick Sleigh Roberts Baronet, Commander in Chief in India appoints Lawrence & Mayo as His Excellency’s Ophthalmic Opticians on the 1st day of March1892
~ 1905
The Industrial & Agricultural Exhibition of the Indian National Congress awards a Gold Medal to Lawrence & Mayo for its Meteorological Instruments.
~ 1906
In May 1906, L&M received a letter from the Prince and Princess of Wales, informing of the receipt of glare protectors.
~ 1923

Her Royal Highness Queen-Empress wearing an AMULET Glare protectors made by Lawrence & Mayo, at the 1923 Wimbledon
Her Royal Highness Queen-Empress wearing an AMULET Glare protectors made by Lawrence & Mayo, at the 1923 Wimbledon
~ 1938
L&M was incorporated under the Indian Companies Act 1913, as a private limited company
~ 1959
I C Mendonca takes over as Managing Director of Lawrence & Mayo and laid a solid foundation for its future growth in India.
~ 1967
I C Mendonca took over the complete organization by purchasing the shares. and Lawrence & Mayo becomes a fully Indian company.
Unbelievable but True

An Indian Crow and his Nest.—The following singular act of systematic theft, carried on by a crow, is literally true. Messrs. Lawrence and Mayo, opticians, have a place of business in Rampart Row, Bombay, and rooms also in Forbes Street, where pebbles and the frames for spectacles are manufactured. The assistant in charge of the latter found out quite recently that a large number of gold, silver, and steel spectacle frames had very mysteriously disappeared. The men employed were at first suspected; orders were given that no one but the manager should have access to the room. The thefts, however, continued day by day; the manager could find out nothing. One Thursday, however, whilst attending to his work, he was startled by hearing the flapping of a bird’s wings at the window, and saw a large crow, which, when it had picked up a frame in its beak, flew away in the direction of the building occupied by Messrs Greaves, Cotton & Co. The bird was observed to carry the frame which it had stolen on to the roof of their building; and permission having been obtained from the occupiers of the premises to go over the roof, the assistant found that the thieving bird had constructed thereon for itself a cosy and comfortable nest, composed of the missing frames. The design of this gold and silver structure was so ingenious, and presented such a beautiful appearance, being so deftly and carefully woven together, that it was decided to keep it intact for a time, and before the materials were unwoven and separated, Messrs. Lawrence and Mayo had a photograph of the nest taken. There were altogether eighty-four frames, of the aggregate value of about 500 rupees (£50), which had been stolen by the bird, and were it not for the fact that it was discovered in time, the poor workmen of the establishment would, no doubt, have got into trouble.

Source: The Selborne Magazine and “Nature Notes” – Volume 7 – 1896

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Some of the distinguished customers of Lawrence & Mayo

L&M’s legion of distinguished customers included the Queen-Empress Victoria, who was provided with a pair of stylish Amulet glare protectors. A few other illustrious customers L&M is proud to have catered to were Mahatma Gandhi, Rabindranath Tagore, Mothilal Nehru, Jawaharlal Nehru, Mohammed Ali Jinnah and JRD Tata.

Old Ad clippings

LifeScienceWorld
LAWRENCE & MAYO
67 & 69, Chancery Lane, London, 16, Old Court House Street, Calcutta, 16, Mount Street, Madras, Forbes Street, Bombay

LifeScienceWorldLawrence & Mayo -Calcutta, Madras, and Bombay – 1892

highlight-2The object of the National Pharmaceutical Pricing Authority (NPPA), is to put in place a regulatory frame work for pricing of drugs to ensure that they are available at reasonable prices to the Indian population.
The Government of India also hopes to come up with all measures for ensuring sufficient opportunity for innovation and competition to support the growth of the pharma Industry.

The New Policy

Under the new policy:-

  • The method of determining the price of drugs would be the weighted average price (WAP), which will be a single average of all brands with 1% share cut off, which will according to ‘ASSOCHAM’ result in 40 – 70% price reduction of the National List of Essential Medicines(NLEM)
  • 348 essential drugs including Cancer and HIV medicines will come under the preview of this policy
Benefits to Consumers

The reduced prices will make available essential drugs to the common man. Thousands of poor and needy will be covered under the basic ‘Health Care’

Benefits to the Pharma Industry

The present cost based method followed by the pharma sector in India creates an inefficient and inconsistent mechanism of price calculation and makes it unaffordable to the poor and needy, further, it creates a monopoly of a few brands. The new policy would create a healthy competition and ensure more volumes of sales due to reduced prices.

Negative impact of the policy on the Pharma Industry
  • The Indian Pharma Companies will be adversely impacted in its profitability
  • Constant pressure to cope with competition to ensure that drugs sold in India are among the cheapest in the World
  • Big foreign pharma companies, who are the leading suppliers of many essential drugs to India may lose interest in investing or expanding production capacity in India

However, the reason the pharma Industry is up in arms against the Government of India  and its drug pricing policy is because of the action of the Government in arbitrarily fixing the prices of anti diabetic and cardiovascular drugs which do not come under the ‘National List of Essential Medicines’ (NLEM) without consultations with the Industry. This has made the Pharma Industry to file an affidavit in the Supreme Court challenging this action. The Supreme Court has also not taken kindly to the Government’s action and questioned them as to how they could fix prices of drugs of anti diabetic and cardiovascular drugs which do not come under the NLEM. The other criteria – extraordinary circumstances also is not satisfied.

If the Government (NPPA) continues to meddle with pricing of drugs outside the NLEM it would make the NLEM redundant and kill the Pharma  drug Industry in India and defeat the very purpose of the new policy which aims to provide sufficient opportunity for innovation and competition for the Pharma Industry for its growth in India.

LSW is of the view that the Pharma Industry is an integral part of the Health Care environment. It would do well for the Government and the Pharma Industry to sit together to find solutions to provide affordable health care to the poor and needy and the most vulnerable sections of the population. The Health Minister’s idea to provide health insurance to all is a welcome step which would go a long way in providing essential health care and essential drugs to the most vulnerable sections of the Indian population.

S.G.B.Rao, Publisher & Managing Partner, LSW

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LSW Conference Final Report

A meeting was organized by LSW to address the problems arising out of the Supreme Court order banning the conduct of clinical trials for new drug discovery programme of Pharma companies. This ban has resulted in uncertainty and major losses. Several foreign sponsors and CROs are affected. It is nearly two years that the ban came into effect and in spite of Govt. efforts the deadlock has not been resolved.
The meeting was held in Mumbai on May 27, 2014 at Hotel Orchid. It was well attended and had participation of the West Zone Deputy Director General of Drugs Dr.Bangarurajan,  and experts like Dr.A K Agarwal,  Dr.Y K Gupta as well as Dr.B M Gandhi. It was chaired by Dr. Surinder Kher, CEO of Ecron Acunova. (The list of participants is given at the end of this report.)
Right at the beginning Dr.Bangarurajan made it clear that he was very sympathetic to the problems faced by drug discovery companies and CROs due to the ban on clinical trials and he would strive to mediate with the DCGI and resolve the issues.
All the other participants made relevant remarks (Given at the end of this report). The meeting concluded on a positive note and a decision to forward the recommendations to Dr.Bangarurajan, who will take it forward to the DCGI. It was decided that a follow up meeting will be held in October/November 2014.

Gist of the conference proceedings:

Dr. B M Gandhi, Former Adviser, Government of India, Department of Biotechnology introduced the conference to the delegates in light of recent amendments to the schedule y of the Drugs and Cosmetics Act, report of the Ranjit Roy Chaudhry, mandatory audio-visual recording of the consent, serious adverse reactions and compensation and registration of ethics committees linked to the topics of the agenda.

Dr. K. Bangarurajan, Deputy Drug Controller (India) gave the inaugural address highlighting the  “Regulations-Past, Present & future Scenario”   highlighting the   implications of the  recent amendments in schedule Y, monitoring the clinical trials, NDACs,  Ethics Committee registration and related issues. 

Dr. Rao Vadlamudi , President, Indian Pharmaceuticals Association in his keynote address highlighted the challenges to bring new drugs to global market in present scenario of clinical research in India and advocated for GCPs in clinical research, enough number of sites, adequate regulatory support, sufficient resources and timely clearances by the regulatory bodies, responsive media for educating public and politicians and political will.

There was an active participation by the representatives of the industry drawn from different areas sharing their view point during session on “My Perspective on Clinical Trials sector in India-Where are we? Where are we going? Where we should be going?”  Significant contributions were made by Jeroze Dalal (Glaxo SmithKline), Apurva Shah (Veeda Clinical Research, CRO), Dr. Prabhash Kumar, Head of Oncology, Tata Memorial Hosp. representing Investigators, Dr. Gururaj Rao, MD International Stem Cell Services Ltd on stem cells trials, Viveka Roy Choudhury, Editor, Express Pharma from the media’s perspective and Shradha Tawade, GM, Wockhardt  (wife of patient who underwent clinical trial).

Elaborated session on “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation” generated good interest and attraction.

Dr. Y. K. Gupta, Professor and Head, Department of Pharmacology, AIIMS discussed detailed information on recent amendments and post-scenario implications on compensation and related issues like basis of calculation of compensation and factors which entitles quantum of compensation. He informed that a Committee is already compiling the suggestions and recommendations in this regard and further suggestions, if any received, would also be considered.

Dr. A. K. Agarwal, Chairman, Compensation Committee, Government of India also informed that suggestions are open for debate and change. He further observed that about 50-60 cases of death are being reported in clinical trials besides subjects reporting permanent or partial damage/disability.

Dr. Milind Antani highlighted the importance of contract with the Project Investigator, Institute and Sponsors; role of CROs and Insurance Package for trial related injuries. Mitigation strategy should deal with liability and project Investigators should also get indemnified under the Professional Negligence Policy.

Other speakers included Dr. Suganthi Iyer of Hinduja Hospital, Jeroze Dalal from GSK, Dr. Venu Madhav, COO, Veeda Clinical Research and Dr. Prabhash Kumar as Panelists.

Presentations were made by industry professionals comprising Yasmin Shenoy , Sr. Director, Regulatory, Sanofi  on “Beneficiary of Clinical Trial”;  Dr. Rashmi Hegde, Director-Medical, Abbott “Liabilities of Stakeholders”;  Deepak Gupta, Asst. Vice President, HDFC ERGO “on New areas of Clinical Trials That Can Be Covered by Insurance “Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim India” Impact on Sponsor Company”; Milind Antani “Contracts” and Prabhash Kumar “Practical Issues and Concerns” These presentations were followed by in-depth discussions

The highlight of the conference was the presence of Dr. K Bangarurajan, Deputy Drug Controller of India, West Zone representing DCGI during the entire course of discussions at the conference and actively interacting with the participants.  He addressed to all their queries on implications of the new guidance media perceptions. In his closing remarks, he assured the participants that he would carry forward all the discussion points and the suggestions made at the conference to the notice of CDSCO, DCGI and the Health Ministry.

 Industry views for submission to the government:
  • Expedite resolution of current PIL by enabling ISCR (CLG, Alishan Naqvi), IPA (Abhishek Manu Singhvi), who have filed an impleadment motion against the PIL, to speak. Or appoint an amicus curiae. This case has been dragging for 2 years now. The government has put in place multiple measures to protect patient safety. It’s time to let CTAs be approved so that patients in India can at least have a chance of hoping for a better life.The gazette notification on compensation is being amended but also needs to be reasonable in the case of outcome or event driven trials where the endpoint is a major CV adverse event. In such trials one wishes to evaluate whether the new drug is able to reduce morbidity and mortality better than standard of care. These are higher risk patients, some of whom will develop these SAEs/endpoints, but if sponsors have to compensate for such events in both arms they will never do such trials in India. Also, if the sponsor’s adjudication of relatedness is not aligned with that of investigator and/or EC there should be an option of going to an arbitrator or the Expert Committee should allow the sponsor to present its case to the Expert Committee.One needs to be able to differentiate between companies who follow strict standardized operating procedures when they conduct CTs all over the world. And companies who flout the law of the land. The former companies’ CTs are inspected by US FDA and EMEA and have passed so many such inspections, attesting to the data credibility and patient safety standards. Some of these companies have been doing global CTs in India for 20 years now and have always adhered to the highest standards of patent safety. Treatment of related AEs has always been paid for by the sponsor.One needs to understand the value to India of global CTs being conducted in India. Patients have benefited. Some have had a prolonged lease of life and get the drug free of cost for life (e.g., in cancer trials). Hospitals get state of the art equipment which they can use post-trial as well, e.g., 6 DEXA machines were donated to the institutes post a trial on a SERM for osteoporosis. Indian patients get access to the cutting edge research early and free of cost and even when the drug is eventually marketed in India it is at a lower price than elsewhere in the world.Operational hurdles need to be looked at rationally. For example, AV recording of the informed consent process should not deny a patient his right to participate if he does not want to be AV recorded. It could be risk-based AV recording, customized to only some patients and some trials which may need this kind of stringency.The CDA bill, if passed in its current state, may dissuade investigators from doing CTs, as the penal provisions may be too sweeping. Be balanced and fair, that’s all we are asking. The Ranjit Roy Chaudhry seems to be balanced. Let’s implement and streamline CT conduct across the country. Industry has always offered to facilitate training of CDSCO on site inspections, etc. Let’s clear the AIR (Academia, Industry, Regulator) by having more face to face interactions, e.g., NDAC is a good example of AIR.In short, we understand why this is happening, although we have always adhered to the highest global standards. We hope that these new regulations will weed out fly by night operators in CR and make India a uniformly clean place to do CTs on par with the best in the world, if not better.

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  • While there are several new regulations and enforcements that are a huge step in the right direction, there are a couple of areas where the intervention and advice of the DCGI office to the Ministry of Health and Welfare will result in a very beneficial position for the Indian patients.

 

  • Retract the video consenting guidelines since this impinges on patient confidentiality
  • Revoke patient compensation clause for cases of placebo related ADRs or absence of therapeutic effect
  • Put in place and enforce stringent timelines for the approval process of New Drugs and CTs for New Drugs

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  • We need to have a mechanism in place for quick approvals for global trials, clarification on some of the clauses where compensation payments are applicable; clarity in formula used for quantum of compensation and accreditation of study investigators. All of these will not only enhance the quality of clinical data generated but will instill a sense of confidence to sponsors conducting future work in India.

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  • Insurance cover for Clinical Trials to be initiated.
  • Special cover (insurance) for Investigators needed.
  • Compensation issues to be made clearer. Compensation granted under labor laws and consumer protection act to be considered while considering the quantum of compensation in clinical trials.

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  • Clinical research is an important step for the advancement of science and benefit of mankind. It must be supported with appropriate regulations and have the right checks and balances.
  • The compensation regulation has progressed considerably to iron out key concerns of all stakeholders
  • Some concerns remain to be addressed : compensation to be paid by sponsor in case of scientific misconduct / negligence by investigator
  • Clinical trial permissions should be expedited

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  • ISCR Suggestion
  • Request CDSCO for a balanced approach for site selection
  • Site with relevant experience, infrastructure and resources to meet the objectives of compliance to protocol, GCP and to ensure safety and well being of the trial participants

 

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Clinical trial requirements

  • First in class drugs
  • Clinical proof of concept is critical
  • Phase 3 Efficacy trials important
  • Best in class drugs
  • Phase 3 superiority trial is critical
  • Biomarkers and clinical trial outcomes evaluations
  • Generics
  • Bioequivalence studies critical

Clinical research, India-specific requirements

  • Clinical research environment with GCPs
  • Enough sites with good research background
  • Adequate regulations to support clinical research
  • Strong regulatory body with sufficient resources to make sound data–driven decisions to accord approvals
  • Responsible media educating public and politicians and a political will!!

People actively involved in the trials should be important stakeholder for the policy formulation for the clinical trials

  •  To include clinical trial as a subject in MBBS curriculum.
  • To include clinical trial as a subject in nurses curriculum
  • To include clinical trial as a subject in administration curriculum
  •  Patient should be considered as a stakeholder in clinical research
  • They should be considered as part of clinical trial development
  • There are many advocacy group in western world, we should also encourage it in India
  •  Clinical trials should be considered a priority in the colleges
  • Infrastructure needs to created for smooth conduct of clinical trials in medical colleges
  •  Trial for marketing and academic studies –This needs to be differentiated
  • Regulation for new drug development and marketing should not apply to the comparative study of drugs available in the market which is freely available in the market
  • There is no funding agency available for drugs in clinical trial in India
  • There should be funding agency eg – DBT, DST which needs to fund clinical trials in India
  •  Clinical medicine and laboratory medicine works separately in India
  • There should be incentives to ensure that clinical and laboratory medicine interact for clinical trials

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Looking at the current scenario of Clinical Trial in India, it is high time that the government increases its participation. The ways to do would be:

  • Drug Discovery sponsor companies → DGCI→IND to Govt. set-up CROs.
  • Trials in government multi-specialty hospitals.

This will remove the problems involved in the CROs which have to make reasonable profit and have to carry out trials even where it is unwarranted.

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LSW Conference: “Clinical Research – Regulatory Norms-Current Challenges and the Future of Pharma industry in India”, May 27, 2014, The Orchid Hotel, Mumbai.

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The objective of this conference was to bring together the regulator and the clinical trial industry to focus on issues related to clinical research/trials area, identify the gap areas, if any in view of the new guidelines released by DCGI office, CDSCO and the Health Ministry and highlight the suggestions / recommendations / solutions consideration of regulatory agencies and wider circulation amongst the clinical trial industry.

Inaugural Session - (From Left to Right: Dr. Surinder Kher, Dr. B M Gandhi, Dr. K Bangarurajan, Dr. Rao Vadlamudi, Dr. Milind Antani)
Inaugural Session – (From Left to Right: Dr. Surinder Kher, Dr. B M Gandhi, Dr. K Bangarurajan, Dr. Rao Vadlamudi, Dr. Milind Antani)

The Conference provided an opportunity to clinical trial industry to interact directly with the regulator, policy makers, legal experts, experts in the field associated with the health ministry and the experts from the industry to discuss recent amendments in Schedule Y; challenges to bring new drugs to global market; perspectives on clinical trial sector in India; compensation and related issues; liabilities of stakeholders and mitigation; other related issues.

There was a good response to the conference and representatives from more than fifteen industries directly involved with clinical trials and more than 30 potential beneficiaries participated in the meeting.

Proceedings:

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Dr. Surinder Kher, CEO, Ecron Acunova- Conference Chairperson
The conference was chaired by Dr. Surinder Kher, CEO, Ecron Acunova, who conducted the day long proceedings so beautifully, that despite long sessions and short lunch break and almost without tea break, the audience stayed put on their seats and interacted with the speakers, panelist and the regulator.

summary-3Dr. B M Gandhi, Former Advisor, DBT, Govt. of India addressing the Conference Overview
Dr. B M Gandhi, Former Adviser, Government of India, Department of Biotechnology introduced the conference to the delegates in light of recent amendments to the schedule y of the Drugs and Cosmetics Act, report of the Ranjit Rai Chaudhry, mandatory audio-visual recording of the consent, serious adverse reactions and compensation and registration of ethics committees linked to the topics of the agenda.

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Dr. K Bangarurajan, Deputy Drug Controller of India, West Zone rendering the Inaugural Address
Dr. K. Bangarurajan, Deputy Drug Controller (India) gave the inaugural address highlighting the “Regulations-Past, Present & future Scenario” highlighting the implications of the recent amendments in schedule Y, monitoring the clinical trials, NDACs, Ethics Committee registration and related issues.
summary-5Dr. Rao Vadlamudi, President, Indian Pharmaceutical Association rendering the Keynote Address
Dr. Rao Vadlamudi , President, Indian Pharmaceuticals Association in his keynote address highlighted the challenges to bring new drugs to global market in present scenario of clinical research in India and advocated for GCPs in clinical research, enough number of sites, adequate regulatory support, sufficient resources and timely clearances by the regulatory bodies, responsive media for educating public and politicians and political will.

This was followed by “View Point” a session titled “My Perspective on Clinical Trials sector in India-Where are we? Where are we going? Where we should be going?” Significant contributions were made by

Jeroze Dalal (Glaxo SmithKline), Apurva Shah (Veeda Clinical Research, CRO),
Dr. Kumar Prabhash, Head of Oncology, Tata Memorial Hospital, . representing Investigators,
Dr. Gururaj Rao, Managing Director, International Stem Cell Services Ltd on stem cells trials,
Viveka Roy Choudhury, Editor, Express Pharma from the media’s perspective and
Shradha Tawade, GM, Wockhardt (wife of patient who underwent clinical trial).

 

Jeroze. J Dalal
Jeroze. J Dalal
 Apurva Shah
Apurva Shah
Dr. Kumar Prabhash
Dr. Kumar Prabhash

                                 

 Dr. Gururaj Rao
Dr. Gururaj Rao
 Viveka Roy Choudhury
Viveka Roy Choudhury
Shradha Tawade
Shradha Tawade

 

Elaborated session on “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation” generated good interest and attraction.

Panelists of Session titled “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation”.From L-R: Dr. Y K Gupta, Dr. suganthi Iyer, jeroze Dalal, Dr. A K Agarwal, Yasmin Shenoy and Dr. Venu Madhav
Panelists of Session titled “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation”.From L-R: Dr. Y K Gupta, Dr. suganthi Iyer, jeroze Dalal, Dr. A K Agarwal, Yasmin Shenoy and Dr. Venu Madhav

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Dr. Y K GuptaDr. Y. K. Gupta, Professor and Head, Department of Pharmacology, AIIMS discussed detailed information on recent amendments and post-scenario implications on compensation and related issues like basis of calculation of compensation and factors which entitles quantum of compensation. He informed that a Committee is already compiling the suggestions and recommendations in this regard and further suggestions, if any received, would also be considered.

summary-14
Dr. A K AgarwalDr. A. K. Agarwal, Chairman, Compensation Committee, Government of India also informed that suggestions are open for debate and change. He further observed that about 50-60 cases of death are being reported in clinical trials besides subjects reporting permanent or partial damage/disability.

summary-15
Dr. Milind AntaniDr. Milind Antani highlighted the importance of contract with the Project Investigator, Institute and Sponsors; role of CROs and Insurance Package for trial related injuries. Mitigation strategy should deal with liability and project Investigators should also get indemnified under the Professional Negligence Policy.

Other speakers included Dr. Suganthi Iyer of Hinduja Hospital, Jeroze Dalal from GSK, Dr. Venu Madhav, COO, Veeda Clinical Research and Dr. Prabhash Kumar as Panelists.

Presentations were made by industry professionals comprising Yasmin Shenoy, Sr. Director, Regulatory, Sanofi India on “Beneficiary of Clinical Trial”; Dr. Rashmi Hegde, Director-Medical, Abbott India on “Liabilities of Stakeholders”; Deepak Gupta, Asst. Vice President, HDFC ERGO “on New areas of Clinical Trials That Can Be Covered by Insurance “Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim India” Impact on Sponsor Company”; Milind Antani “Contracts” and Prabhash Kumar “Practical Issues and Concerns” These presentations were followed by in-depth discussions.

 

Yasmin Shenoy
Yasmin Shenoy
Dr. Rashmi Hegde
Dr. Rashmi Hegde
Deepak Gupta
Deepak Gupta
Dr. Viraj Suvarna
Dr. Viraj Suvarna
Dr. Milind Antani
Dr. Milind Antani

 

 

(Some of the other panelists: L- R: Dr. Viraj Suvarna, Dr. Rashmi Hegde, Dr. Kumar Prabhash, Deepak Gupta, Dr. Venu Madhav and Dr. Milind Antani)
(Some of the other panelists: L- R: Dr. Viraj Suvarna, Dr. Rashmi Hegde, Dr. Kumar Prabhash, Deepak Gupta, Dr. Venu Madhav and Dr. Milind Antani)

The highlight of the conference was the presence of Dr. K Bangarurajan, Deputy Drug Controller of India, West Zone representing DCGI during the entire course of discussions at the conference and actively interacting with the participants. He addressed to all their queries on implications of the new guidance media perceptions. In his closing remarks, he assured the participants that he would carry forward all the discussion points and the suggestions made at the conference to the notice of CDSCO, DCGI and the Health Ministry.

Closing Remarks by Dr. K Bangarurajan, Deputy Drug Controller (3rd from left). Others in the pic. (From L-R) Dr. Milind Antani, Dr. Surinder Kher and Dr. B M Gandhi
Closing Remarks by Dr. K Bangarurajan, Deputy Drug Controller (3rd from left). Others in the pic. (From L-R) Dr. Milind Antani, Dr. Surinder Kher and Dr. B M Gandhi

The details of the discussions and the recommendations made at the conferences and comments would be available on this site soon.

Steroids – How safe are they as medicine?

What are steroids? Also known as Cortisone or Corticosteroids are Hormones that occur naturally in the body.

Steroids decrease inflammation, suppress the body’s immune system, block DNA from being made and also block chemical called ‘histamine’ released during an allergic reaction. ‘Steroid medicines’ are manmade but similar to the natural hormones.

Oral Steroids are medicines taken by mouth in the form of pills, liquids etc and used to treat medical conditions like inflammatory bowel disease (Crohn’s disease, ulcerative colitis ), auto immune diseases like auto immune hepatitis, joint muscle diseases like rheumatoid arthritis, poly myalgia rheumatica, allergies and asthma. It is also used in treating certain types of cancer and as replacement for patients who cannot make their own steroids (Addison’s disease).

Examples of oral steroids are Betamethasone, Cortisone, Deflazacort, Dexamethasone etc.,
Predinisolone is the most commonly used oral steroid.

Steroids – How safe are they as medicine?

Side effects of Oral Steroids

A short course of steroids (1-2 weeks) usually causes no side effects. Side effects are more likely to occur when taken for more then 2-3 months or repeated short courses. The higher the dose, greater the risk of side effects.

A common treatment plan often adopted by doctors is to start with a high dosage to control symptoms and gradually reduce to a lower daily dose that keeps symptoms away. The length of treatment varies depending on the disease. Sometimes it may be stopped gradually if the conditions improve. However, in certain patients it is needed for life.

 

Steroids – How safe are they as medicine?

The main side effects of taking steroid medicine are:-

  • Osteoporosis
  • Weight gain
  • Increased chance of infections
  • Increase in blood pressure
  • High blood sugar
  • Skin problems like thinning skin, easy bruising, and stretch marks
  • Muscle weakness
  • Risk of developing cataracts
  • Increased risk of duodenal and stomach ulcers
Important things you should know about Oral Steroids
  • Oral steroids should not be stopped suddenly and only supervised by a doctor
  • Do not take inflammatory pain killer (ibuprofen etc) whilst taking steroids unless advised by the doctor.

S.G.B.Rao
LSW LifeScienceWorld