The Department of Biotechnology (DBT) is seriously contemplating to amend and modify the Protocol 5 of the Mashelkar committee report which was adopted by the government in 2005. The provisions of the Protocol 5 allow the traders to market imported biotech products in India without undertaking any clinical studies in the country.

The Protocol 5 of the Mashelkar committee which was jointly formulated by the DBT and the Ministry of Environment & Forests enables all the traders to import and market any biotech products into the country without undergoing any clinical trials or studies in the Indian population. Whereas, the indigenous manufacturers from the country have to undergo clinical trials and fulfil other necessary regulatory steps before launching their products in India.

According to Dr K K Tripathi, advisor, DBT, “We have observed that this provision is creating an environment wherein the domestic players are getting affected, whereas the traders are benefiting due to the difference in law, as they have to follow very few regulatory requirements compared to their counterparts.”

If the government gets enough representation from the industry, it is contemplating to act on this, so that it can provide equal opportunity to the the indigenous manufacturers and put a stop to the unfair competition in the market that is being practised now due to the provisions of Protocol 5.

At present, any trader can market biotech products in India provided that those products are duly approved by the regulatory authorities from the country in which the parent company is based from without undertaking any studies in India. Dr Tripathi informed that the government is contemplating to change this law as it will provide unbiased and equal opportunity to all, to market their products in the country.

He added that with enough representation, the government will be able to take pro-active steps to ensure enactment of new regulations to regulate the products that are being marketed in the country. The DBT proposes to modify protocol 5 by making it mandatory for all the traders to generate relevant data on clinical studies and trials that are conducted on Indian subjects before marketing the imported products into the country.

“We believe that it is imperative for any traders to generate data on clinical studies conducted in the country in which the product is expected to be marketed as the effectiveness of the product may vary according to demographic requirements,” informed Dr Tripathi.

However, he pointed out that it is ironic that though there have been reports of discontent over the protocol 5 by the industry members, none of the associations or the companies have come forward actively expressing their concern over it. Dr Tripathi stressed, “Our main aim is to provide an impetus to the Indian industry to grow and establish itself more prominently in the country as well as internationally with the help of strong regulatory framework. Keeping the interest of the domestics manufactures in mind, we are hoping that with enough representation we will be able to bring some strategic change in the report.”