‘A Huge Bogey’s Made About Compulsory Drug Licences’
A huge bogey is being made about India’s position on the compulsory drug licensing system, says
secretary of the ministry of commerce. She says the government is taking an extremely conservative view of the provision and the public health requirements. Speaking to
on the sidelines of a pharmaceutical conference in Mumbai, Teaotia says India will not sign any international pact if it jeopardises the Indian public’s access to affordable healthcare. Edited excerpts:
How do you plan to grow pharma exports from India? We already have an industry the size of $32 billion and that is just for the pharmaceutical products. This is one segment where exports is growing at close to 10%. We have a few sectors that bucked the trend of last year’s export decline, but the pharmaceutical industry stood out as a shining example. Some companies grew their exports at over 30%. What we need to see now is to have this scale in areas such as ayurveda, biologics, herbal products and devices. We are working to ensure that our industry takes strong roots. We have to expand the scope of our industry not as a pharmaceutical industry but healthcare industry, which goes from research, education, clinical research, medical devices and hospital care to drugs. Some of the biopharma products based on ayurveda are completely unique to India and we want to focus there. This is one sector about which you cannot help but be optimistic in India. Global pharma lobby groups have spoken about ‘unwritten assurance’ given by India on not issuing compulsory licences and that has discouraged companies from applying for new licences. Your thoughts?
I believe there is no such assurance. A huge bogey is made about compulsory licenses. Since the Act (Indian Patent Act) came into force, only one product has gone for this. It is ridiculous to make such a bogey. If there is a public health requirement, it will need to be addressed and will be looked at extremely conservatively as we have done so far. We cannot give such assurances to any country nor any industry groups. On the contrary, companies have seen a lot of value in going for voluntary licences. The benefits of partne- ring with Indian companies offers access to other countries, products of highest quality and at the most optimum pricing.
Health activists say the supply of low-cost drugs to many countries may be compromised if India agrees be a signatory to the Regional Comprehensive Economic Partnership and the EU Bilateral Trade and Investment Agreement... We do not believe in giving any assurances or undertakings at this point of time that would jeopardise access of Indian public to affordable healthcare. We are extremely positive and extremely pragmatic about both of these agreements. We are very interested in both these agreements.
The USFDA’s measures against Indian drug makers have been in focus for some time. Will you engage at a government-level discussion to handle this? As far as the measures taken by FDA are concerned, I think regulators have the right to do what they believe is appropriate in the interest of the health of their population. So, what they do is fair enough. But the issue is how well equipped are the Indian companies to respond to this. The government supports our industry. Not one Indian company will compromise on the quality and they are able to meet the requirements of such very demanding markets. This is borne out by the fact that for the very year that the FDA made several interventions, our growth has been 33% in the same US market during the last financial year.