Drug Regulation

Delhi High Court Grants Biocon-Mylan Permission to Market New Biosimilar For Additional Indiciations

As reported in the Economic Times on March 4, 2017 a Division Bench of the Delhi High Court has passed an interim order allowing Biocon and Mylan to market their biosimilar of Roche’s drug, Herceptin, for two additional indications: early breast cancer and metastatic gastric cancer. (Although this order was passed on March 3, 2017 it took the High Court’s registry almost 13 days days to make available the order on its website. It is not clear why it took so long to make the order available and one really does hope that the Registry of the Delhi High Court does a better job in putting out these orders quickly.)

Prior to the passing of this order, Biocon and Mylan, had permission to market their product for only metastatic breast cancer. This lawsuit which was filed by Swiss company Roche against the Drug Controller General of India (DCGI), Biocon and Mylan over the approval process followed during the grant of approvals for the biosimilar of Herceptin has been contentious from the very beginning. The case was listed before Justice Manmohan Singh who passed a series of controversial orders against Biocon and Mylan including a judgment running into 227 pages. I’ve argued earlier on this blog that Roche’s lawsuit has no basis in law. It is simply impermissible to challenge statutory functions of regulators in civil lawsuits in India. Rather, the correct approach would have been to file a complaint with the DCGI followed by a writ petition against the DCGI alleging a violation of either the Constitution or the statute itself. Hopefully the Division Bench hearing the matter will pass a conclusive judgment on this issue over-ruling Justice Manmohan Singh’s previous orders in this regard.

The larger issue that remains unresolved is whether India has a safe and prudent policy in place to approve these biosimilars. As we have explained in our earlier posts, approving biosimilars is very different from approving generics. Given the nature of these drugs, it is necessary for those following the innovator into the market to conduct clinical trials before they can establish the safety and efficacy of their products. In its latest order, the Division Bench makes it clear that it is giving permission to Biocon and Mylan to market their biosimilar for additional indications because the DCGI had already approved the biosimilar for this purpose. The High Court did not go into the merits of the DCGI’s decision and actually examine the process of approvals because it cannot do so in civil proceedings.

The one question that should however keep us all up at night is whether India does in fact have a credible legal framework in place to oversee this rather complex regulatory process. As somebody who is familiar with the working of the DCGI, I have little faith in the institution. It is grossly incompetent and unaccountable. To boot, the legal framework granting these approvals consists of certain “guidelines” released jointly by the Department of Biotechnology and the DCGI’ office (i.e. the CDSCO). Only god and the government know why this route of law making was adopted because “guidelines” by their very definition merely “guide” the authority – which means there is no accountability in case of a violation of the guidelines. To be binding as law, the DCGI should have amended the Drugs & Cosmetics Rules, 1945 or alternatively should have asked the Ministry of Health to move Parliament for amending the Drugs & Cosmetics Act, 1940. Other countries like the United States have introduced new laws like the Biologics Price Competition and Innovation Act, 2009 to create credible new regulatory pathways for biosimilars. India on the other hand is operating under a legislation enacted by the British in 1940.

God Save Us!

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

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