"India has a competent enough system to check quality standards"

The $25-billion Indian pharma industry is going through intense regulatory scrutiny. Foreign drug regulators such as the US Food and Drug Adminis-tration (FDA) and EU's European Medicines Agency have increased their inspections of Indian drug manufacturing plants that export medicines to those geographies. Individuals and civil society groups - both within the country and outside - are seeking better regulatory mechanism for Indian drugs manufacturers. In an exclusive interview with Business Today's Joe C. Mathew, Drugs Controller General of India G.N. Singh says that Indias drug regulatory mechanism is not as bad as it is often made out to be, though it may not mirror the systems that exist in the developed world. Edited excerpts:

A US citizen had recently approached Indian courts to re-draw the 'archaic' domestic drug regulatory rules. The complaint was that Indian regulatory system is in shambles. Do you agree?

It is true that the Drugs and Cosmetics Act was framed in 1940, but that does not mean that it is inadequate to take care of issues related to safety, effectiveness and quality of the drugs. The overall governance of drug regulation is based on the rules under the Act. The Drugs and Cosmetics Rules are dynamic in nature. So the over- arching framework may not have changed, but the rules are up to date. If you see our country in totality, and look at our regulatory system in an overall integrated fashion, you will find that our regulatory system is competent enough to meet the issues of quality, assess the overall effectiveness and overall patient safety. The issue, which people often flag, is the gap that exists between the USFDA and our drug regulatory system. It is a different issue. Depending on the social, economic and other factors, each country will have its own set of regulatory system. The fundamental thing that we need to look at is whether we compromise the safety and quality of medicines or not. We don't compromise.

The complaint is not only against the law. It is also against the level of enforcement?

Traditionally, the enforcement in this country has been weak. That was because our regulatory institutions were seen as licence giving institutions for a long time. Enforcements were there, but not in the manner it should have been. None of the stakeholders - be it industry, or the patient, were ready for that at that time. But now, things have improved. In the last decade or so, there has been a paradigm shift in this approach. Each state is strengthening its regulatory mechanism, so is the Centre. In 2011, we had only 33 people in the central drug administration system. Today we have more than 300 and we are planning to add another 200 shortly. So, that is the overall approach today. And it is need based. The industry has matured, and the regulator is becoming well equipped and knowledge-intensive. The focus now is on enforcement.

Indian companies are being accused of following double standards when it comes to quality. Is it true that the medicines they export to the US are far superior than what they make for India?

The US regulator inspects the services, practices (of USFDA approved Indian manufacturing facilities) from the lens of their regulatory perspective. We see it on the basis of our statute. But the fundamentals remain the same. Both of us look at it from the point of safety and efficacy. As I have already mentioned, we look at it from the affordability angle, too. In that sense, we ensure that all basic WHO (World Health Organization prescribed) quality requirements are followed. We want to pick up a number of good things that USFDA follows. But we don't want to follow it blindly. Our issues are different. This is the reason behind this complaint that Indian companies have double standards and they are giving good medicines to US and bad medicines to India. Obviously, the people who make such allegations have some vested interests.

But still, isn't it a valid question?

The question is, quality at what cost? As I said, there is no compromise on safety and efficacy. Quality is a dynamic thing for both products as well as services. Quality means different for different persons and locations. For medicines that are manufactured for consumption by Indian population, affordability is important. Someone might want the medicine in blister pack, someone might want it in a bottle. Someone would be very particular of its appearance, and they want it completely white. Someone will allow some colour variation if it meets all quality and safety specifications. As regulators we need to keep a balance, without compromising the quality, efficacy and safety.

Your recent decision to ban a significant number of fixed dose combinations (FDCs) has been criticised by the industry. They say that they were not consulted before banning time-tested drug combinations. Your comments.

When two or more drugs are mixed together, its overall pharmacological and therapeutic claim gets changed. It will have an impact on the overall effectiveness of the medicine. Four years ago, we started a massive exercise to weed out the combination drugs that have got no therapeutic impact or use on Indian population. In 2012 itself we had a meeting with the industry representatives in Mumbai where I sought their help to shortlist such FDCs. A government appointed high-powered committee (which recommended the list of FDCs that requires to be banned) had also sought industry views before giving its recommendations. So, I don't agree that industry was not consulted.

Is there a plan to strengthen the regulatory system for medical devices?

Medical device is an untapped area where we see huge potential. India has to take the lead here as most of the medical devices we use today are imported. How long, with such a huge population, will we depend on imports? The government is thinking to ease regulations in medical devices. Unfortunately, some of the medical devices were made part of drugs. And that created confusion within and outside the country. We are trying to sort this out. Government is going to classify medical devices as per the international practices soon. Globally, medical devices fall under the jurisdiction of drug regulators. Similar system will be in place here also.

Will it be governed by Drugs and Cosmetics Act, or will there be a separate Act?

That will be decided by the Parliament. We feel there should be separate verticals to handle medical devices, cosmetics and biologics in the regulatory department.

The government has come out with a draft biosimilar guideline. Will it be aligned with international best practices?

The future lies with biologics products and inventions. India is having huge skilled manpower that needs to be trained in this field. We need to recreate the success we had in chemical drugs in biologics also. Thats why we have come out with the draft biosimilar guidelines. They are guiding documents. They will guide us while we assess the fundamental issues of quality and safety and effectiveness of biosimilars. As in the case of our generics, in biosimilars also the regulation will keep in mind the overall safety and quality factor, and affordability. The guideline is India specific.

India had a booming clinical trial industry some years ago. The sector lost its sheen due to regulatory interventions. Is a revival possible?

The 2012 period and before was a very troublesome phase for the country as a whole in conducting clinical trials. The rights, safety and the well-being of the subjects of the clinical trials were denied at that time. We did not have a proper regulatory mechanism in place. That was the cause of all the problems. It took some time to build that expertise. I can tell you with certainty that India is ready to do extremely good work in clinical trials now. Our share in global clinical trials today is just 1.46 per cent. We have created a platform through which India will become a preferred destination for clinical trials. In the next eight to 10 years our contribution to the global clinical trial industry should be at least 10 per cent. That's the plan. That will create a huge job opportunity. It will also result in huge skilled manpower for drug discovery research, where exactly India's true strengths lie.

E-commerce has become a reality. What is wrong in allowing online medicine sales?

The existing statute does not permit online sales of drugs. A high-powered committee of experts is examining this issue. We are awaiting their recommendations. The issue is very complex. The Europe, the US and other countries are struggling with this. We want to use this technology, but only after complying with all regulatory requirements.