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DIPP may seek information from DCGI to manufacture generic version of Roche's anti-cancer drug

NEW DELHI: The government may check readiness of the pharma industry to manufacture a generic version of Swiss drug major Roche's anti-cancer drug Trastuzumab before considering the issuance of a compulsory licence for the drug, according to officials .

The Department of Industrial Policy and Promotion (DIPP), the nodal body for issuance of compulsory licences, may seek information from the Drug Controller General of India (DCGI) on whether any generic drug maker has sought marketing approval for the drug, and how long would the approval process take if such an application was made.

The DIPP is currently considering a health ministry proposal to issue a compulsory licence for Trastuzumab under Section 92 of the Indian Patents Act, which empowers the government to notify the need for such a licence on the grounds of national emergency, extreme urgency and public non-commercial use.

DIPP may seek  information from DCGI to manufacture generic version of Roche's anti-cancer drug


Worried over the exorbitant prices of the drug in the 
Indian market, the ministry urged the Department of Industrial Policy and Promotion to invoke this section. It has cited extreme urgency and public non-commercial use as the basis for its request. Some patent experts, however, told the government that a window of opportunity for compulsory licence based on 'extreme urgency' cannot be left open for an indefinite period after notification.

This probably prompted the government to first check whether there were any willing takers for the Trastuzumab compulsory licence, said a patent expert on condition of anonymity.

"It is important for the government to first test the waters on whether there are companies ready to take the compulsory licence and manufacture the drug. If a CL is issued and there are no takers, it would be embarrassing," said Ramesh Adige, former president of Ranbaxy Labs.

He said while the government may be keen on companies applying for CLs under Section 84, it was not a feasible option for most drug makers considering the litigation costs involved. "Many companies with capabilities may shy away from applying for CLs also because they have marketing tie-ups with innovator firms," Adige added.

But civil society groups say announcement of a compulsory licence for Trastuzumab will encourage domestic pharma firms to step up their 
investments in ongoing research projects for biosimilar development, expediting the entry of these drugs in the Rs 70,000-crore domestic market.

"A CL opening up competition to Roche's Trastuzumab from other manufacturers has the potential for a global impact and can send a strong message. Indian companies have already developed biological products such as rituximab and pegylated interferon. There are several manufacturers who have trastuzumab in the pipeline as well," said Leena Menghaney of Medecins Sans Frontieres, an international medical non-profit organization.

Roche, the Swiss innovator firm, which markets Trastuzumab in India under the 'Herceptin', commands a near monopoly in this market here. Roche had launched the drug at over 1 lakh per vial.

However, following India's decision to grant its first compulsory licence on liver cancer drug Sorafenib (Nexavar), Roche in March 2012 announced a cut of over 15% in the price of Herceptin per dose to 92,000. It also tied up with Indian drug maker 
Emcure Pharma, which started offering the drug under brand Herclon at 72,000 per dose.

Separately, in March this year, the 
Cancer Patients Aid Association had requested the government to revoke the patent on Trastuzumab. But the DIPP ruled that out in July, saying the patent office was already hearing a case of 'post grant opposition' on the matter. In April 2008, Glenmark Pharma had filed an opposition to the patent in India. "The patent office has kept the post grant opposition to the trastuzumab patent pending for five years without even constituting an opposition board. This is unacceptable," Menghaney added.