Intellectual Thoughts by Sanjay Panda


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

Generic drug manufactures to pay more for registration in US


US FDA recently made amendments to introduce a generic drug user fee. According to the new law, The Generic Drugs User Fee Amendment (GDUFA) of 2012 — companies will have to pay a fee ranging between $17,435 and $51,520 an application to seek an approval. Besides, drug makers will also have to pay for inspection of their facilities by the FDA outside the US, and for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.
According to US FDA, companies will have to pay $17,434 per generic drug application pending without tentative approval till October 1. For applications seeking generic drug approval on or after October 1, companies will have to pay $51,520, whereas for Drug Master File companies are required to pay $21,340.