India has to maintain global regulatory standards to remain the pharmacy of the world: Ex DCGI

India wants to become self reliant in manufacturing and innovation in bulk drugs. That is why the Prime Minister, over the last few years, has given special emphasis on developing pharma parks across the country. In this context, the UP Chief Minister decided to develop a bulk drug park in his state. And we want to make sure that if any international incident happens, since the geopolitical situation is in a troublesome phase, then we can be self-reliant. In such cases, India has to be ready to address issues like healthcare. We (India) are known as the pharmacy of the world since we supply medicines to more than 200 countries. So we have to see that the continuity of supply of medicines remains undisturbed.

When you talk about the geopolitical situation, are you referring to the excessive imports of Active Pharmaceutical Ingredients (APIs) from China?

Majority of our APIs are being imported from China. It is the thinking of experts at the highest level that India has to be fully self-reliant. We are, but due to cost prohibition, we were lacking in API production. Now with bulk drug parks coming up, the cost of production will also come down and we will become competitive in the international market and hopefully begin supplying APIs to many others, especially Europe and other developed markets. We will capture those markets based on quality, prices and uninterrupted supply.

There have been complaints coming in from many nations, including Africa and Europe and ones flagged by the USFDA, regarding the quality of drugs going out from India. How do you see this in context of the way ‘made-in-India’ medicines are perceived abroad?

As scientific systems are developing, the regulatory landscape is also changing. We are continuously adjusting the regulatory system so that the regulator meets the expectations of scientific rigour and the people. Safety, efficacy and quality of medicines is of paramount importance to the regulator and to end users everywhere. So, we want to make a harmonised approach so none of the issues lag behind the science requirements. Both the Drugs and Cosmetics Rules and the Indian Pharmacopeia (IP), which is the book of standards for drugs, are continously being upgraded to address these issues.

So, does the Indian drug regulator need more teeth? Is stricter regulation required today?

The requirement is to strengthen the drug regulatory system in terms of science, in terms of manpower, in terms of the execution of mechanism and the government must be thinking on those lines because it is aware of these issues. If we want to remain the pharmacy of the world we need to maintain the standards of global science and regulation.

The most recent debate is regarding generic drugs. There have been problems highlighted with regards to bioequivalence studies and doctors are pushing back against compulsorily prescribing them. How do you see this issue?

It is only a myth. These issues have been raised multiple times and as a scientist, I am of the firm opinion that the book of standards is the same for branded, branded-generic or generic medication.

If you take the Indian, US and UK Pharmacopeias, they are not ascribing different standards. They are all the same — right from manufacturing systems, quality control and testing before batches reach the market.

So, I don’t agree that generic drugs are in any way less than the branded medicines and it is just a myth with no basis in scientific parameters. They are almost equal in my opinion and I had made it very clear on various forums, including international ones, not just as a former drug regulator of this country, but also as the head of the Indian Pharmacopeia Commission. I appeal to the doctors and to the people to accept generic medicines as ones at par with the branded ones.