India plans to tighten the regulatory noose around pharmaceuticals imports from China through stricter scrutiny of active pharmaceutical ingredients (APIs), key starting materials (KSMs) for medicines and medical equipments.
India imports more than 53 critical pharma APIs, including those used in tuberculosis medicines, steroids and vitamins from China. It also imports raw material for medical devices, pharma packaging material like plastic, polymers and small components for medical equipments and devices from China.
“Firms have told us that they have adequate stocks in the inventory and so far, trade relations are running smooth. But this is not so much an immediate issue. The aim right now is to reduce import dependence on China — not just in pharma but all sectors — most importantly in pharma because this is crucial and India is dependent on China for API,” an official in the department of pharmaceuticals said. He said government is working towards reducing import dependence so that in case of tensions between the two countries, India’s drug supply is secured.
The domestic API manufacturing industry, mostly based out of Hyderabad and Ahmedabad, currently accounts for 8-10% of India’s over Rs 1.33 lakh crore pharmaceutical market. The rest comprises formulations. Now, Indian drug makers are also exploring options in EU markets to source APIs and other raw materials. India is likely to source more APIs from Germany, Sweden and Italy, even as it also ramps up local production.
At present, 30-35% of API imports are from these countries, while China caters to the rest. However, India may have to deal with cost pressures as China supplies products at 25-30% cheaper than other markets. “Supplies from China are crucial not only because of the price factor but because these are routine products used in huge quantities. India produces complex API molecules on its own but their use in formulations is limited,” an industry executive said.
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