Package to boost API manufacturing soon

The Centre would soon announce a package of incentives to companies making active pharmaceutical ingredients (APIs) and drug intermediates for increasing the production of raw materials used in formulations.

Department of Pharmaceuticals joint secretary Sudhansh Pant disclosed this on Tuesday evening without giving definite time lines for the announcement but said it would happen in a few months from now.

A proposal to implement a comprehensive strategy to support the bulk drug industry had been in the works for quite sometime with the industry and policy makers expressing concern over the increasing dependence on cheaper imports from China.

Without naming China, Pant said the dependence on imports of APIs and intermediates had grown substantially in one of the major challenges facing the country and "a particular part of the world" dominating our import basket.

According to the Indian Drug Manufacturers Association (IDMA), China alone contributes 58 per cent to all such imports by value and in volume terms its share is almost 80 per cent. The Indian pharma industry imports metformin, analgesics paracetamol, ranitidine, vitamin C and its intermediates and many products from China in large quantities, though all these could be produced in India, the IDMA had said in a white paper submitted to the government last year.

Pant said the government was also planning to encourage cluster development of small and medium bulk drug and pharmaceutical units by providing common facilities such as effluent treatment plants.

"The idea is that if they are provided facilities, they too can open up to global markets like the big pharma players in the country," he said while participating in a panel discussion at the CEO conclave of BioAsia, held on the Indian School of Business (ISB) campus.

According to Pant, the Centre is also contemplating to re-launch Jan Aushadhi stores with a new name and in large numbers. The government wants to make generic drugs accessible to people at a much lower price compared with branded generics, he said.

On ethical marketing practices, he said the government would be having a detailed round of stakeholder consultations in May or June on the six-month voluntary compliance of the regulations issued on January 1, 2015.

The government would then decide whether to extend the voluntary compliance period or to make them mandatory depending on the situation.

Responding to a question on the separate set of regulations for medical devices, he said a new chapter dedicated to the medical devices in the Drugs and Cosmetics Act had been written and kept in public domain for feedback as the present regulations in this respect are very week.