The regulator has told drugmakers and industry groupings to submit the price movement, production details and inventory of active pharmaceutical ingredients (APIs) and key starting material (KSM) of 58 crucial APIs that are imported from China.
The APIs are used in antibiotics, vitamins and other essential medicines, and are heavily sourced from China. These APIs are paracetamol, aspirin, azithromycin, amoxicillin, ofloxacin, metronidazole; vitamins such as B12, B1, B6, and E; female hormone progesterone; HIV drugs lopinavir and ritonavir; and blood pressure-controlling drug valsartan.
According to a memorandum by the National Pharmaceutical Pricing Authority (NPPA), the companies are supposed to furnish details in a format regarding the stock in hand, average selling price as on November 2019 and February 2020, and quantity imported in 2018-2019 and in January 2019-2020.
“As part of public health preparedness, in respect of APIs, intermediates, KSMs which are imported from China, a committee was constituted by the department of pharmaceuticals (DoP). The committee has identified 58 significant APIs for monitoring of their availability and to take preventive measures over illegal hoarding and black marketing in the country,” said the memorandum issued by the NPPA dated February 26.
The companies have to submit these details by March 3.
The government has been examining the impact of the shutdown in China on the pharmaceutical sector in India. The DoP has also asked the country’s drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), to examine to what degree India depends on China for bulk drugs, possible shortages of molecules and measures that can be taken to keep the situation under control.
As a long-term measure, to attain self-sufficiency in bulk drugs and reduce dependence on China, the government is contemplating ways to encourage domestic manufacturing of APIs by creating a suitable ecosystem in the country with a focus on fiscal and procedural support to pharma companies to kickstart production of intermediates.
A recent meeting in Niti Aayog suggested building production capacity for these 58 APIs for which India is significantly dependent on China. The NPPA had on February 20 also asked the chief secretaries of states and Union territories to closely monitor the production and availability of APIs and their formulations to prevent black marketing and hoarding.
“It may also be ensured that there is no violation of the provisions of DPCO, 2013 with regard to compliance of ceiling prices, permissible increase in prices of scheduled/ non-scheduled formulations,” reads the NPPA letter.
