Ramesh Kumar recently took charge as new commissioner of the Maharashtra Food and Drug Administration, replacing A. Ramakrishnan. Earlier he was the principal secretary of tribal development department, Government of Maharashtra. Ramesh Kumar is an IAS officer from the 1975 Maharashtra cadre.
One among his main initiatives after taking charge as the Commissioner was an offensive against a dozen odd domestic and overseas companies and their distributors, who market drug eluting stents for cardiac patients without either valid drug manufacturing licence or approval from the Drug Control General of India for marketing the product in the country. In an interview with Kavita Tate of Pharmabiz, he reveals the details of the stent issue and his plans of strengthening vigil against various unethical practices followed by industry and trade in the state. Excerpts:

You have taken charge as the commissioner of state FDA recently, and the Johnson & Johnson baby oil issue is still a hot topic of debate. What is the current status of that issue and what action have you taken?

Johnson & Johnson has responded to our directive and informed us of their willingness to correct the label of their baby oil. Company has been given time till August 1 to make some necessary changes on the label. The company has informed us of its willingness to display a safety warning and declare all the ingredients on the label instead of only "key ingredients". Their suggestions are being examined and we are yet to take a final decision. Wipro, has already agreed to remove the word 'baby' from its label of baby oil and market the product as an emollient and not as baby oil.

What was the basis of your offensive against the Netherlands co, which markets drug eluting stents in Mumbai hospitals?

We came to know that the Netherlands-based company Occam markets its drug-eluting stent 'Xioon' in Mumbai hospitals without any valid approval from either the Drug Controller General of India or state drug controllers for the past few years. Since the drug eluting stent contains drug and is implanted into the body of the patient, it is mandatory on their part to get prior approval from Indian drug control authorities. It is violation of section 3-B (4) of the Drugs & Cosmetics Act 1940 and we have powers to take action against such violations.

What follow up action have you taken on this?

We identified and directed at least 10 such companies and their distributors to get a valid drug licence for marketing drug eluting stents in the state. These include Johnson & Johnson's Cypher Sirolimus-eluting coronary stent), Boston Scientific, Bangalore-based medical devices company Vascular Concepts (pronova), Singapore-based Intek and its distributor Elder Pharma (Apollo), B. Braun (Coroflex Please), Meditronix (Endeavour), Sarin of Germany and its distributor Strenco (brand Jenus), Conor Medi Systems of Germany (Indian distributor IUTL) and brand (Coesta) etc. At least 10 to 20 companies are found in the Indian market, including Chinese and Korean companies. We are in the process of identifying these companies and their distributors in Maharashtra. Of this, some companies have US FDA and EC certification from EU countries. So in order to help the patients using these products, we have given an interim arrangement for these companies to submit their US FDA and EC certification, besides approval from their respective country drug administrations, until the Indian government takes a decision on such products. We have also informed the DCGI about the issue and the matter is pending before him.

Recently the state FDA launched initiative against few companies selling nutraceuticals with therapeutic claims. What is your stand on such cases?

With the proposed Food Supplement Bill and amendments to Drugs and Magic Remedies Act, such violators could be checked in a better way. FDA's stand is very clear. Any product that is used for the therapeutic use should have a drug licence and must be sold as a drug and not as a food supplement. According to the law, any substance that is used for therapeutic purpose requires a drug license. The time given to these companies to take valid drug licence is up to July 1 2005. In case of violations, strict action under the law would be taken against these companies that includes cancellation of licences, prosecution etc.

There was a move to make air-conditioning compulsory in medical stores in the state so as to preserve and prolong the potency of medicines. Are you going to pursue this matter with the pharmaceutical trade?

This is no longer an issue. Even if we make a move to make air- conditioning compulsory, will the government assure 24 hours electricity? Further, it is practically not possible to have air conditioners in each and every medical store of Maharashtra. As far as potency of the drug is concerned, most of the drugs require storage at the room temperature and normally, RT is quite low as compared to the temperature outside. Further, drugs that require cold storage are stored in refrigerators. Why make laws that cannot be enforced? It is impossible to close down all medical stores without air-conditioners, as it could lead to shortage of drugs.

Absence of pharmacist at the retail pharmacies while delivering the drug is very common in Maharashtra. Do you have any plan to ensure the presence of pharmacists at the retail counters?

This is another area that is important and we will find the solution for it as soon as possible. There are not only widespread complaints of absence of pharmacist at counters but, also of bogus employment and part- time appointment of pharmacist. To keep a check on this we will have surprise checks to retail pharmacy shops. In case of first violation, we will warn the owners or give some minor penalty. In case of recurrent violations severe actions would be taken against them.

There are reports that half of the FDA staff lack adequate knowledge on Drugs and Cosmetics Rules and there is a severe shortage of drug inspectors. There has been no new recruitment of inspectors since last 12 years though many posts are not filled. Your comment.

These reports are baseless. May be some of our staff does not know all the Drug rules. But this does not mean that we don't know FDA's responsibility. We know our rules and responsibility very well. As far as the recruitment is concerned it is with the government and not with FDA. But we will ensure that the posts are filled as early as possible.

Manufacture and sale of spurious drugs is growing at very fast pace in the state. What steps are you planning to control this menace? How many prosecutions you have carried out so far during last year?

Every month FDA tests about 600 to 800 drug samples. Out of these, about 50 or 60 samples on an average are of substandard quality and some are spurious. In such cases we issue notices to companies manufacturing these drugs or to the companies under whose brand names they are manufactured. There are certain provisions of penalty for those manufacturing spurious drugs, in the new bill passed by the government. Strict enforcement of law would help to control the manufacture and sales of spurious drugs.