New Delhi: A religious chant is playing in the background at the office of M. Venkateswarlu, the drug controller general of India (DCGI), who’s just been given a six-month extension. The drug regulator has been in the hot seat over the past few months over issues such as the ease with which fake drugs are sold in the country, the transgression of ethical standards in human clinical trials and the sale of drugs and medical devices in India that may be harmful to patients. In an interview interrupted by meetings with his minister (of health and family welfare Anbumani Ramadoss), Venkateswarlu tells Mint why the going is not as bad as it seems and shines light on the path ahead. Edited excerpts:
You have six months more as the drug controller general of India. What are your top priorities?
The first priority is to strengthen my organization and operations. There are various posts lying vacant that we are looking to recruit in and we are trying to create some additional technical posts under contract. We have a sanctioned strength of 81 and only half that number is filled in. We want to increase the total number to 100.
Second, we want to write out guidelines for procedures in filing applications (for various permissions required such as launching a new drug or commencing manufacturing). All these procedures are in the law, but they are not easy to understand for the applicants. Our work gets duplicated several times over due to incomplete applications, which we can save by streamlining a little. We’re trying to
Opposite ends: Drug controller general of India M. Venkateswarlu says the philosophies governing price and quality are very different
make it simpler for stakeholders and make it available on our website.
About 30-40% of the applications get rejected as they are incomplete and these can be weaned off, saving that much of time for other things as well as reducing the time for clearing an application.
Thirdly, I would like to address this issue of extent of counterfeit drugs in the country. (The DCGI has proposed a nationwide survey to estimate the incidence of such drugs in India.) We just want to have a realistic figure. (A) pilot study on 4,000 samples in western India had identified merely 0.2% of such drugs. Counterfeit drugs per se are not harming anybody in the sense they are complying by and large, with all the requirements of a drug, as per chemical synthesis. When I test it, it passes every (laboratory) test. Counterfeiting is (more) an economic offence.
Fake drugs has been a big issue in India. The European Commission, too, has come down hard on the country over this issue. What are you doing about this?