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Grey areas in pharma sector need for urgent care

M. Bhaskaran
Tuesday, November 28, 2017, 08:00 Hrs  [IST]

The twin issues of e-pharmacy marketing of nutraceuticals either as food supplements or as vitaliser/nutrient, and marketing of leading brands by manufacturing these drugs is not so well known companies are of concern to the public. These issues are being briefly dealt in this article in the larger public interest based on my personal experience. This is not intended for or against any segment in the above sector, but purely from a consumer perspective.

Everybody comes across this term in daily news papers with opinion for and against it with news of a proposed creation of portal for e-pharmacy for its regulation. There were also news that existing laws under D&C Act and Rules there under cannot control this mode of sale. At the outset let me inform that though there is no specific provision on this, one can take action under the D&C Rules 1945 {Rule 65 provisions] as these sales may not confirm to these provisions in letter and spirit.

Supporters of e-pharmacy may cite the current trend of marketing of all items in day to day life starting from groceries, vegetables up to all household items including electronic items, wherein the client makes an order by sitting at home or office and the goods are delivered at the appointed date and time of choice of client. The reason for this growth may be the current busy life of everybody in a family leaving no time for these to be made in person at its marketing place. The moot question is whether one can compare these purchases with the drugs prescribed by a doctor for certain illness.

Though nowadays one may feel taking drugs is like a food, or its purchase being not so stringent with controls as may be needed, food and drugs are entirely two different categories, as everybody knows it. (We might have forgotten the saints {Siddhers of Tamil Nadu], who have advocated that the food we take is drug as each vegetable item has its own medicinal uses). Further, in case of all items other than drugs we may know whether it is good or bad quality based on our known perceptions for the same based on earlier use. This cannot be the case with the drug as here one may not know whether the item received is the one ordered for.

The ease of getting it online with its comforts by being at home cannot be accepted for the simple reason that anyway the patient has to go to see a doctor as only after personal examination, a doctor will prescribe drugs. When a doctor visit can be done, why not the prescription cannot be shown to pharmacy nearby and medicine purchased. Nowadays we have enough pharmacies unlike in the past. We [in the department, during an investigation] had a sad experience of seeing the sale of drugs by getting answers for certain symptoms and getting the opinion of a doctor for issuing a particular category of drug [of course we had a successful prosecution here].Can we have or afford to have such online consultation without seeing the patient, when our earlier method of family physician is seeing and having a feel by touch, examination. [nowadays the advice is first go to family physician and then on his recommendation go to the concerned specialist instead of the patient himself going direct to a specialist wasting his/her time of the specialist]. Whether it is good for general public health to get drugs on line?

Further I refrain from any opinion on the possibility of movements of counterfeit drugs/spurious drugs in this method of supply and its traceability in this on line sale as any new regulation is yet to be notified.

In a pharmacy in the current setup, as per the Act, the pharmacist is required to take out the drugs as listed in the prescription, record it in the prescription register and then prepare bill for the items sold. Hence, the responsibility can be fixed in this setup, but can we do so in an online marketing firm, where the packing, billing and forwarding may not be having that much control.

From my limited exposure and knowledge during my recent visit in US, I have not heard of this in spite of my specific query to a doctor friend there.  [I mention US, since normally we compare ours with that in other countries like US] Even here after a visit to doctor/specialist, the prescription goes online to the nearest pharmacy and the drugs collected from there only.

As far the protagonists for e-pharmacy, may say it is secure, safe with adequate controls with the provision for patient comfort/ease in getting drugs, when all other items are marketed like this way. It will be very difficult to accept the above arguments and may be dismissed, but well, I expressed the views in public interest

Nutraceuticals and food supplements
This is another flourishing category in the market, some being manufactured by leading drug manufacturers. In my view, it was noticed first in 1983 to 1990 period and then started to move away from the category of drugs to Food supplements/nutraceuticals for various reasons of the manufacturers. Though it is known and certain regulations are contemplated, lot needs to be done. Now at the most they market under FSSAI label. What is worrying from this category is that the quality is not/cannot be assured, as in the case of drugs, for certain technical reasons and people take it without any worry as mostly these items have vitamins, minerals being suggested for general health as a nutrient, vitaliser. But, some quality control is needed as samples of these may not be lifted for testing by drugs inspectors in view of label claim of food supplement. By close scrutiny of label and its claim on the label, some action can be initiated.

These items do not attract the DPCO 2013 as they do not claim to be drugs and are not coming under the definition of drugs as prescribed in this order. A small comparison of an item under drug and a similar composition marketed as food will make one to feel the difference in price between the two.

Drugs under marketed by arrangements
The D&C Act and Rules has provisions for manufacture of drugs under Loan licence system, wherein the loan licencee utilises the manufacturing facilities of a licenced manufacturer to manufacture drugs of a particular category under his/her supervision. Initially, in the experience of author of this article, its issue was limited with only limited number of items and limited loan licencee per manufacturer to ensure quality of the drugs [around 1980s]. But, slowly this has developed wide. Another method is manufacturing drugs under marketed by arrangements by having an agreement between the brand holder and a manufacturer. In this category, the manufacturer may not have marketing of the drugs manufactured by him, but has enough job to run his factory. I will only mention here that close monitoring is needed in these categories to ensure quality drugs [it is from my experience and study by causing simultaneous sampling throughout the state of all drugs under a particular category of drugs and analysis within a limited time frame].

It is suggested that a suitable control system is developed in this regard to ensure availability of quality drugs at affordable cost to the poorest of poor with public interest at large.

(Author is retired director of drugs control,
Tamil Nadu and former consultant, TNMSC)


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