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
make it simpler for stakeholders and make it available on our website.
Opposite ends: Drug controller general of India M. Venkateswarlu says the philosophies governing price and quality are very different
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?
The countrywide survey we are planning on this issue is shaping up pretty well. We are at an advanced stage and have to look for a statistically significant drug sample size as well as select the brands. It has to be a time-bound, high-speed process. It’ll not just give a reliable estimate of the extent of the counterfeit drugs, but also help me to undertake consequential action where such medicines are found.
In our experience, (in) 99% of the cases, counterfeit drugs are of standard quality but they don’t belong to the original manufacturer. Spurious drugs, with 0% medicine in it, may not exceed 0.3%. However, one cannot encourage any clandestine activity because even if it doesn’t make a difference to the customer, his faith in the drug has to be retained.
We had asked for clarifications from the European Commission, but haven’t yet received an answer. What we understand is that they have got data from customs seizures where intellectual property violations may also get picked up. An IPR (intellectual property rights) violation cannot be called a quality violation. It could be a standard drug but may be unregistered or without a patent. In Nigeria, for example, an unregistered drug may be smuggled. A lot depends on your ability to monitor the quality of drugs entering your country.
Some important bills are coming up in this session of Parliament…
There are two bills concerning us that are going to be tabled in Parliament. One is on stringent punishment (for offenders caught making or selling spurious drugs) and the other is for creating a Central Drug Authority (CDA).
What difference will CDA bring to the functioning of the drug regulation in the country? Will drug price control, too, be eventually brought under CDA?
The first major change in going from DCGI to CDA will be that of a government department becoming an autonomous body. Secondly, we are asking for a fourfold increase in the strength of drug inspectors (from about 25 at the Centre today). Then there will be clearly defined 10 divisions that will look after different areas (clinical trials, new drugs, medical devices, cosmetics, vaccines and biologicals, consumer education, good manufacturing practice-compliance, etc.)
Another (important move) is the shift of licensing powers of drug manufacture from the states to the Centre. Our contention is that there is a need to harmonize varying levels and approach of drug regulation in various parts of the country. There are 27-30 players (licensing authorities) in this field and this is where the Centre needs to come in. Even globally, people expect us to do that as they accept one authority in one country and not 30 authorities. In international communication, nobody can directly communicate to the states.
Price control (by the National Pharmaceuticals Pricing Authority) requires its own expertise. The one looking at quality will find it difficult to look at the price angle. There is a clash. The philosophies are very different.
Why is the state of pharmacovigilance so poor in the country? Why do we have to wait for a drug to be investigated in the West for adverse health effects rather than having our own studies on the Indian population? Avandia is a case in point. (Avandia, a GlaxoSmithKline Plc. drug to combat diabetes, has come under the spotlight with fears of cardiac adverse reactions.)
We have just started our pharmacovigilance programme two years ago. For a country of our size, it takes time for any new system to be adopted. There are only 25 centres and you need a very big network to cover the entire country. Most importantly, the medical profession has to be motivated and educated for reporting the adverse drug reactions (ADRs) as they alone, while treating their patients, can find such events.
One part is understanding and reporting an ADR and then there is investigation to see if ADR was caused by the drug or by something else. Building on this process takes time. You can’t blame the drug for anything and everything unless it is proved. Rome was not built in a day, so is the case with pharmacovigilance. (Other) countries have taken two-three decades to reach where they are now, (for us) it may take at least 5-10 years.
So, wherever ADR is reported, we examine it. We have a focused scrutiny on that molecule. The (drug) approval is based on a risk-benefit analysis. There may not be a drug without any ADR, it is the risk versus benefit that we look at and this is a variable factor due to changes in disease profiles, epidemiology or discovery of newer drug categories. In certain cases, we take the limited risk of permitting to launch the drug in the market and continue to study if that risk is increasing or not.
We would like to know and take a judicious call on our own. Just because (countries in) the West have done it, we won’t do it. At the same time, if something has been pointed out in the West, we will like to have a critical examination.