In view of the over-dependence of the domestic pharma manufacturers on China for their raw materials need, India’s drug controller is planning to hold a meeting with them next month to review the supply situation at home.
The move, majorly follows increasing demand for ban on import of overall products from China in view of its opposition to a UN ban on Jaish-e-Mohammed chief Masood Azhar.
In fact, India is a key supplier of generic and affordable medicine for the world market but at least 65 per cent of its requirement for crucial bulk drug raw material is met from import from China. India’s Active Pharmaceuticals Ingredients (API) is particularly dependent on imports from the neighbouring country for the manufacture of 12 important medicines, including paracetamol and amoxicillin.
The API is the organ by which active pharmaceutical ingredients are manufactured from raw materials through both chemical and physical means.
Drug Controller General of India (DCGI) GN Singh agreed that in case of emergency, the country should be prepared to meet the raw material need of the manufacturers so that output is not suffered. "We might call the meeting on November 9-10 to deliberate with the manufacturers to how to increase the internal capacity.
"Moreover, to reduce dependency on pharma imports, special bulk drug zones are being set up in Vishakapattnam in Andhra Pradesh and in Chennai. We are proposing another at the UP," Singh added.
Expressing concerns at this dependence on China, a joint paper by business chamber ASSOCHAM and market research company RNCOS released recently too noted that though the government has taken steps like withdrawal of exemption in customs duties , imports worth Rs 13,853 crore in 2015-16 or 65.29 per cent of the total imports of Rs 21,216 crore are not sustainable.
"This is likely to affect the bulk drug manufacturing sector, and subsequently have an impact on our population in plausible scenarios of drug shortages brought down by interrupted imports from single source country", ASSOCHAM Secretary General D S Rawat said. He added that such system is not advisable from India's overall strategic interests as well.
One of the main reasons for huge API imports from China is low cost of its manufacture and subsidy in China while India levies negligible import fee . "The import fees should be increased in line with other counterparts", the paper said.
It also said that the Centre can focus on development of mega parks for APIs across the country. These parks should be provided with common facilities such as effluent treatment plants, testing, power plants, IPR management and designing. These facilities should be maintained by special purpose vehicles (SPV).