India is the third largest pharmaceuticals producer in the world, yet, there is over dependency on China for certain active pharmaceutical ingredients (APIs)/bulk drugs, intermediates and key raw material as well as fermentation technology. The nation is fully reliant on Chinese raw material for making antibiotics. Pharmaceuticals Export Promotion Council (Pharmexcil) is taking steps to reduce this over-dependency on China. The council had been talking to Chinese regulatory authorities and China Chamber of Commerce for Import & Export of Medicines (CCCIEM) to promote exports to China to maintain the trade balance. India today imports USD 2-2.5 billion worth of pharmaceuticals (raw material, ingredients and intermediates) while the nation exports only USD 200 million worth of pharmaceuticals to China. Pharmexcil has signed a memorandum of understanding (MoU) with CCCIEM in August 2018 and established a help desk to facilitate both Indian companies already exporting to China and those that are looking at China. Training programs had also been conducted for Indian pharma companies with China Food & Drug Administration (CFDA) and Chinese trading agencies to learn the regulations and Chinese market better. About 170 Indian companies received CFDA training.
Task Force created
The council has submitted a proposal to the Department of Commerce, Ministry of Commerce, Government of India, and created a Task Force comprising of CSIR Labs and industry. The Task Force has identified some key basic raw materials that are needed to make active pharma ingredients (bulk drugs) and has proposed creation of industrial clusters to make bulk drugs to combat Chinese companies on the price front, as affordability is becoming a challenge. Pharmexcil director general Ravi Uday Bhaskar told Telangana Today, “The Task Force constituted by the Department of Pharmaceuticals comprises of secretaries of Health and commerce and Department of Pharmaceuticals, industry bodies such as Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Association (IPA) and Bulk Drug Manufacturers Association (BDMA) along with Pharmexcil director general. Minister of State for Chemicals and Fertilizers Mansukh L Mandaviya is chairing the task force. Pharmexcil is going to prepare the detailed project report. We have identified some of the products that India should make. Center has to decide which Indian companies should make these products is yet to be identified. A manufacturing policy has to be drawn out in this direction.”
He added, “It is critical for India to make drugs which are in the National List of Essential Medicines (NLEM). Most of the active pharmaceutical ingredients are being sourced from China for these basic drugs. If China stops supplying certain material, there will be challenges both in terms of meeting domestic health needs as well as exports. China is raising the prices constantly, and it is time for India to take steps to come out with a policy for manufacturing process. The Center is taking account of the situation and Pharmexcil is also representing these issues in appropriate platforms.” Though India has strengthened its presence in the formulations front, there is still large dependency on China for active pharma ingredients. China also supplies several raw materials for non-pharma sectors such as chemicals. So, the issue is not just with pharma but with multiple sectors. Measures are being taken in India to improve self-dependency. Uday Bhaskar says, “We need to watch Bangladesh closely in the coming years as pharma companies there are getting US FDA approvals and they are looking at export markets. Competition is going to increase.” – Telangana Today