India’s drug price regulator, the National Prescription Pricing Authority (NPPA), will tomorrow (July 31) consider requests from domestic drugmakers to raise their product prices, as they struggle with inflation, the rising prices of active pharmaceutical ingredients (APIs) and intermediates and the current scarcity of Chinese supplies of these materials.

Indian drugmakers have come to rely on China for 80% of their APIs and drug intermediates. However, ahead of the Olympic Games, the Chinese government has now banned exports from domestic facilities which have failed to adhere to pollution control requirements, and many of the units which are still in production have increased their prices as much as 50%. As a result, Indian firms are now reliant on their own stockpiles of raw ingredients, which are fast running out.

Some manufacturers are asking the NPPA for a 20% price increase, which is double the current 10% ceiling for products which are not under official control, while others have requested that the current process, under which price rise applications have to be made by individual companies, should be streamlined and based on the most recent invoices to indicate current trade and retail price levels. The NPPA has pledged to reduce the time it takes to assess price rise applications to 30 days, from a current maximum of 60 days.

The firms also point out that they cannot pass their cost increases on to consumers, and they warn that shortages of some products may be inevitable.

Opportunity to revive India’s bulk drug sector?

The situation has also been discussed this month in talks between the NPPA, Indian manufacturers of raw materials and the Ministry of Chemicals and Fertilisers’ newly-formed Department of Pharmaceuticals, which is said to regard the API import crisis as an opportunity to revive the bulk drug sector in India; this has declined dramatically in recent years as a result of cheap imports from China.

The new Department of Pharmaceuticals was established on July 2. Its purpose, according to a government statement, is to “give greater focus and thrust to the development of the pharmaceutical sector in the country and to regulate various complex issues related to pricing and availability of medicines at affordable prices, R&D, protection of intellectual property rights and international commitments related to the pharmaceutical sector which require integration of work with other Ministries. There is also a need for better coordination in the areas of pharmaceutical R&D and education, and for international cooperation in these areas.”