FDA VS CHEMISTS An Ongoing Battle

It seems an extension of controversy that started a few months back between Food and Drug Administration (FDA) Maharashtra and chemists in the state. A few months back, FDA’s objection to entertain prescriptions from non allopathy doctors met with strong protest from chemists as well as non allopathy doctors. Moreover, this controversy caught both the FDA and chemists in a dilemma of choosing between ethics and rules. Even the Maharashtra Government struggled to find out an amicable solution. Now, perhaps the same old story is getting repeated. But the location hasn’t changed, characters are the same too, only the script is different. FDA’s recent raids on chemist shops that were working without a registered pharmacist are justified. However, on the other hand, industry experts are also surprised at the sudden and desperate response of FDA to such chemist shops. A stitch in time saves nine, goes an old saying. Unfortunately, the FDA didn’t understand this sooner and perhaps woke up late to an emergency.

Raid rampage

FDA raids are as per the laid down rules and should be supported by any law abiding individual. However, fingers have been pointed towards FDA’s approach and not at the rules. How come so many illegal chemist shops have cropped up and survived for so many years in the first place? What had stopped FDA from raiding such shops before, which have now grown become a major problem?

Sudhir Deshpande, Legal Consultant, Pharmalex, doesn’t find FDA’s raids sudden. According to him it is not correct to say that this is FDA’s sudden outburst against chemist shops in Maharashtra. “This is an ongoing process and FDA, Maharashtra State has been taking penal action against the chemist shops for violation of conditions of licenses especially selling Schedule H drugs without supervision of a registered pharmacist,” says Deshpande, while backing his opinion. He adds, “It appears, FDA decided to resort to the campaign and concerted action as the instances of selling drug without supervision of the registered pharmacist, selling drugs without prescription, diversion of habit forming drugs for non medicinal use etc. have become major problem over last few years.”

One reason that is been put forward for not conducting raids before was the lack of drug inspectors. Dilip Kadam, Executive Member, All India Organisation of Chemists & Druggists (AIOCD) and Maharashtra State Chemists and Druggists Association (MSCDA) says, “Basically there were no sufficient drug inspectors earlier and hence the law could not be implemented even if anybody wanted to do so. The period of lack of inspectors was too long, therefore there was nobody to keep any control on the chemists.” Kadam stressed that there was no dispute between the chemists’ association and the FDA. Everything was working in cordial relations as a very few inspectors were in the FDA who could not make regular inspections as per the law till Mahesh Zagade, FDA Commissioner, Maharashtra State, came into the picture. Kadam informs, “Very recently 92 inspectors have been recruited.”

“The pharma companies have also erred to a certain extent. This is by increasing the number of capsules in a strip in order to swell the one time purchase by the customer, thus looking for a larger turnover of the product and thus the revenue.” Subramanian Vaidya An industry expert

According to Subramanian Vaidya, an industry expert, there were a lot of complaints about unauthorised stocking and sales of some products in the hormonal segment and that too without prescriptions. Drug inspectors also noticed that the sale of such products were being effected by unqualified staff at the pharmacy outlets. “The entire move seems to have been mooted after this episode. This was because a lot of complaints and sufferings in the form of adverse effects at the patients’ level. There could be other reasons too. However the main one could be that such sales and consumption of these products were harmful to customers at large and that too without any monitoring of the sales,” says Vaidya.

To be or not to be

However, there always two sides to a story. The problem that arises while cutting the tablet strip is one of the many examples where this fact gets clearly underlined.

“Raids are an ongoing process and FDA, Maharashtra State has been taking penal action against the chemist shops for violation of conditions of licenses especially selling Schedule H drugs without supervision of a registered pharmacist.” Sudhir Deshpande Legal Consultant, Pharmalex

As per Deshpande, the provisions of Rule 65(9) of the Drugs and Cosmetics Rules, 1945 are clear and there is no ambiguity as to whether tablets strips should be cut or not. If the prescription of schedule H drugs is for six tablets, it is mandatory for the chemist to sell only six tablets by cutting the tablets strip. The ability of compliance of conditions of licenses and Rule 65 depends on the mindset of the chemists. Over the period of last few years, under the pretext of practical difficulties, chemists have developed a tendency of not complying with the rules.

However explaining the chemists’ point of view, Kadam points out the dilemma associated with the cut tablet strip. He says, “After giving the loose tablets, the remaining strip should have the requisite batch number and its expiry date. FDA should address this issue by giving guidelines to the manufacturers. The rules are very clear but they should go hand in hand with other related acts and rules.”

Vaidya brings pharma companies into the picture. According to him, pharma companies also have a role to play in this scenario and discusses some critical issues associated with the pharma industry. He stresses, “The pharma companies have also erred to a certain extent. This is by increasing the number of capsules in a strip in order to swell the one time purchase by the customer, thus looking for a larger turnover of the product and thereby the revenue. There are many examples on this at the chemist front. Obviously when the doctors prescribe medicines to the patients, they are not well informed of the packaging by the company and this leads to miscommunication.” He adds, “Besides daily wage earners and weaker sections of the society would like to buy bare minimum as one time purchase. This calls for cutting of strips at the chemists’ level.”

However Vaidya argues, “Strip cutting results in not being able to track and trace batch numbers and expiry dates and dispensed. Rules are existing in FDA , but they have not been progressively reviewed and changed so as to meet the changed circumstances. Hardly any governance has been done in this area. Companies do all sorts of tricks and manage to get the maximum out of a prescription and rightly so.”

Lack of resources

A large number of chemist shops in Maharashtra, working without proper license or registered pharmacists, had to pull down their shutters due to FDA raids. A move applauded by many but in several cases, the chemists have their own justifications. There was just one pharmacist in many chemist shops because the shop owner couldn’t afford to employ two pharmacists to work in different shifts. So, chemists who tried to run shop in two shifts had to go without a pharmacist in one of the two shifts. To make the situation worse for chemist shop owners, Maharashtra doesn’t have a sufficient quantity of registered pharmacists. So in this scenario, where there is a demand supply gap, can the raids by FDA be justified?

“It is true that to run shop in two shifts, a chemist shop would require two pharmacists and that Maharashtra does not have sufficient registered pharmacists to work in the chemists shops. No accurate data is available as to how many of registered pharmacists have left for a career in countries out of India, how many are working in government and railway hospitals, how many are working in the pharma industry or any other field,” opines Deshpande.

However he also cautions, “Notwithstanding the problem of non availability of sufficient registered pharmacists, FDA cannot allow shops to run without supervision of registered pharmacists.” He emphasises, “The problem has become chronic not because of the non availability of pharmacists but because of entry of large number of shopkeepers in the profession by appointing registered pharmacists only for the name sake. FDA’s action will result in driving such elements out of the profession and it will be certainly beneficial to the law abiding chemists.”

“Basically there were no sufficient drug inspectors earlier and hence the law could not be implemented even if anybody wanted to do so. The period of lack of inspectors was too long, therefore there was nobody to keep any control on the chemists.” Dilip Kadam Executive Member, All India Organisation of Chemists & Druggists (AIOCD) and Maharashtra State Chemists and Druggists Association (MSCDA)

Kadam provides statistical count of the number of pharmacists. He says, “There are 1,30,000 registered pharmacists in the state and around 50,000 retail shops in every nook and corner of the state. Almost 10,000 pharmacists come out of the colleges every year. Maharashtra is second in number, with the maximum pharmacy colleges. So, there should not be a scarcity of pharmacists. However today the position is such that looking at the state population, behind every 2000 people there is one retail shop.”

Dr Laurence J Peter, a world known educator, describes bureaucracy- “Bureaucracy defends the status quo long past the time when the quo has lost its status.” Vaidya explains, “Any raid cannot be justified by FDA at this moment. FDA could have been more transparent while granting licenses. Unfortunately in some cases licenses have been given when there was actually no need of it. FDA indeed has a very good batch of officers. FDA commissioner’s intentions are noble too and cannot be questioned. However, in some exceptional cases loopholes were being thoroughly exploited by the subordinate authorities for giving away licenses. There could be built in gains in this in terms of convenience and money exchange. Needless to point out that the employed pharmacists, as they are less in number, sign up with more than one outlet allowing malpractices to seep in.”

Will budding pharmacists get demoralised?

Pharmacist usually do not get good salaries at the chemist shops. There is a question mark over job satisfaction as well, as chemist shops are not identified as an industry. Now recent controversies associated with this profession must have added to the worries of the budding pharmacists. Will such frequent fights associated with this profession make aspiring pharmacists look for other jobs?

Vaidya provides critical and realistic views, “Pharmacy degree holders are not interested in this type of work and they consider this below their dignity. They always lean towards white collar jobs in a pharma company in various departments like marketing, production, regulatory, R&D, clinical research and so on. These jobs also bring considerable increased amount of wages and incentives along with perks. This leads to a gigantic gap in terms of emoluments drawn by a pharmacist degree holder and diploma pharmacist in a chemist shop. There is hardly any social esteem for a diploma pharmacist in a pharmacy outlet.”

However Deshpande disagrees and does not think that it will be difficult to attract good pharmacists. “In fact, the campaign by FDA will create better opportunities for pharmacists keen to work in chemists shops as full time pharmacists. Closure of shops not employing full time registered pharmacist will also create an opportunity for self employed pharmacists,” says Deshpande, while showing the silver lining to the controversy.

So the bottom line is that FDA’s endeavour towards strict implementation of rules is commendable. However, the issues generated out of FDA’s raids are also the outcome of FDA’s own lethargic attitude. Its efforts to implement the laid down rules can always be justified but with such sudden outbursts, FDA itself is making room for these raids to get questioned. As far as patients are concerned, they are more bothered about the delivery of the right medicine, at the right time. FDA and chemist shop owners should ensure that they would not stoop to the level that would degrade their credibility in the eyes of patients by becoming a source of entertainment.

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