T P Gopinathan, Drug Controller, Kerala, is in his current office since November 2001, and is instrumental in bringing in many innovative and bold decisions to streamline the drug industry in the state. For example, he is the first drug controller in the country to introduce the distance factor to curb mushrooming of chemist outlets. Similarly, Kerala is the first state to introduce amendment in Kerala Narcotic and Psychotropic drug rules to make available morphine tablets freely and easily, removing the control exercised by the State Excise Department.
He joined the Kerala drug control department in 1971, and for a five-year stint, he took leave and worked for a private pharmacy in Al Jubail, Saudi Arabia. P B Jayakumar of Pharmabiz.com spoke to him recently. Excerpts:
The drug control department in Kerala has been in the forefront to introduce many emulative strategies against erring units. Would you kindly brief us on some of the recent initiatives of the department?
We are still sticking on to the norms of distance factor in allowing retail chemist outlets. Until recently, many medical shops were mushrooming in different parts of the state, ultimately affecting the traders themselves due to intense competition and causing inconvenience to the public. With the rules on distance, we have been able to ensure drug stores are available to the public at the most required places, than concentrating at a few places. Similarly, Kerala is the first state to introduce amendment in Kerala Narcotic and Psychotropic Drug Rules to make available morphine tablets freely and easily, removing the control exercised by the State Excise Department. The department regulates the supplies of narcotic drugs like Morphine, Pethidine etc. The DC is the authority to approve palliative care centres as recognized institutions for possessing oral morphine preparations.
I think we are probably the first drug control mechanism in the country to book nutraceuticals with therapeutic claims. A recent such example was the seizure of some of the Amway products sold through the multilevel marketing network. Kerala is a big consumer market and many companies eye this as a market with potential consumers ready to welcome any new or innovative products. It is a fact that many drugs are sold under the guise of herbal food supplements and other nutraceuticals. The tag of herbal or Ayurveda and sales through medical stores or MLM network helps them reap the riches and escape the clutches of law. Though the D&C Act is not strong enough to strictly curb them, there are provisions in it to book such units.
Nevertheless, it is a fact that most of these firms escape the clutches of law unhurt. Isn't it?
It is the problem of our system. Sometimes the legal proceedings may take many years. In between, the cash rich firms may field high profile advocates in courts and may get a stay on the action of our department and continue to sell the same in the market. Similarly, some of the drug laws are weak to book these units. For example, we took a case against a manufacturer for advertising his cholesterol drug. He chose to accept the punishment rather than challenging the verdict in higher courts, as the punishment possible under that crime were not much rigorous.
Unlike many other countries, we have a system of control over manufacture and trade of drugs and the industry is bound to obey these rules. In the case of our drug control department, 176 cases are pending in various courts. About 155 cases were under investigation and 20 prosecutions were conducted during the 2002-03 period, of which only 14 cases ended in conviction and six cases were acquitted. Now many new cases are being detected. We have decided to constantly monitor the drug supply to the Government hospital pharmacies as there are reports of malpractices, pilferage and supply of substandard drugs.
What is the organizational set up of the Kerala drug control department?
The department regulates 97 drug manufacturing units, 127 blood banks, 46 cosmetics manufacturing units, 18 homoeopathic medicine manufacturing units, 892 Ayurvedic manufacturing units, besides 12,480 allopathic drug sales premises and 668 homoeo sales premises. There are 47 sanctioned posts of drugs inspectors for inspection of allopathic drugs (including homoeo) sales premises. There are 6 senior/regional drugs inspectors, three drugs inspectors (Ayurveda), besides one senior drugs inspector and one deputy drugs controller of Ayurveda.
Recently we have set up a separate licensing authority for Ayurveda and this is sure to considerably reduce my workload, though the powers for inspection and penal action are still with the drug controller's office.
What about the expansion of the drug control laboratory?
Our drug control laboratory at Thiruvananthapuram is undergoing a major capacity expansion to test 5,000 samples in a year from the existing 3,000 samples. This project is under the capacity building project of the central government, which has funded Rs 59.5 lakh in the 10th Five Year Plan for augmenting facilities of the lab with sophisticated equipment, furniture and other infrastructure and the project is likely to be completed by 2005-06 period. We have been sanctioned to recruit five analysts and support during this year.
The lab was strengthened with a new pharmacological section and condom testing section and was commissioned during October 2002. We have a separate analytical division for Ayurveda with facilities to test 300 samples in a year. In fact, we had urged the setting up of a regional drug testing lab in Kochi, but the approval is still pending with the Government.
What about the prevalence of spurious drugs in Kerala?
It is proud for us to state that Kerala could be the only state in the country that has completely tackled the menace of spurious drugs, thanks to our efficient and very active Intelligence branch and other drug enforcement officials. I would confidently say that the prevalence of spurious drugs is zero in the Kerala market, except recently we had seized a few spurious cosmetic manufacturers. Drug control officials have powers to enter any premises which deals with any kinds of drugs and our officials are given a free hand in this inspection process. According to a rough estimation, it is said that 2.3 percent of the drugs in the state market are of inferior quality, and once our lab is upgraded, we hope to better tackle this problem.