Indian Regulator sets deadline for drug launches

Pharmaceutical companies will have to launch drugs within six months of getting approval from the drug regulator, failing which they could lose the manufacturing license.   According to the Indian Drugs and Cosmetics Act, for any new drug, pharmaceutical firms should file a periodic safety update report (PSUR) every six months, for the first two years and  once in a year for the subsequent two years.  This enables authorities to monitor the safety and efficacy of a new drug in a post-marketing scenario for four years, after which it no longer remains a new drug.

“It has been decided in public interest that in case an applicant/manufacturer fails to launch the product for marketing in the country within a period of six months from obtaining the permission or license, the permission/licence will be treated as cancelled,” said the DCGI

AstraZeneca's Cancer drug Patent Plea Rejected in India

In a setback to AstraZeneca, the Intellectual Property Appellate Board (IPAB) has dismissed its appeal against an earlier ruling that refused it a patent on lung cancer drug Gefitinib. The Indian patents office in 2007 refused patent protection to AstraZeneca, citing lack of invention. The Intellectual Property Appellate Board (IPAB) now upheld the refusal.

In its appeal, Astra Zeneca earlier had argued the controller had erred on various aspects of patent determination and also in concluding that the comparison test did not establish increased efficacy of the drug.

Innovators  suffered a reversal in March when India granted the first ever compulsory licence to Natco Pharma to sell Bayer's cancer drug Nexavar  equiavalent. Bayer has appealed  against the order.

And early this month IPAB revoked a six-year-old Indian patent granted to Roche's hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments.

Source:  newspaper & media reports