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Web Date: January 3, 2018

India’s drug security threatened by reliance on imports

China supplies two-thirds of raw materials
Department: Government & Policy
Keywords: Pharmaceuticals, Pharmaceutical chemicals, India, China
Metformin, which is used to treat diabetes, is one of the active pharmaceutical ingredients that India imports from China.
Chemical structure of metformin.
Metformin, which is used to treat diabetes, is one of the active pharmaceutical ingredients that India imports from China.

Concern is growing in India about pharmaceutical companies’ dependence on low-cost bulk drug imports from China to meet escalating demand for pharmaceuticals at home and for export.

Although India is a key supplier of formulated generic and affordable medicines to the world market, it imports bulk active pharmaceutical ingredients (APIs) from China, Germany, Italy, Singapore, and the U.S. China alone accounts for 66% of crucial raw materials, especially antibiotics.

Indian companies are capable of manufacturing the APIs in needed quantities, but the compounds can be imported at lower cost, India’s Minister of State for Chemicals & Fertilizers, Mansukh L. Mandaviya, told India’s Parliament on Dec. 19.

The dependence on bulk ingredients imports is increasingly viewed as a national security risk. The draft Pharmaceutical Policy 2017, unveiled by the government in August, says, “One of the major areas of concern is a very high dependence on import from one or two countries for the raw material and intermediates needed for manufacturing drugs. It has a direct bearing on the drug security of the nation as a whole.”

Pharmaceutical companies in India generally do better than those in China when it comes to Good Manufacturing Practices, says Niranjan Singh, a pharmaceutical industry consultant. To make them more competitive on cost, India’s pharmaceutical companies are seeking corporate tax breaks, cheaper electricity, flexible and simple environmental regulations, faster drug approvals, and antidumping duties on products that are abundant in India.

The Indian government had started in 2016 to develop API manufacturing parks with infrastructure such as better power supplies and waste treatment plants. That effort is currently in limbo as the government tries to figure out how to finance the projects.

The government in 2016 also terminated an exemption on customs duties for import of 76 bulk drugs. Low-cost bulk drug imports from China subsequently dropped from a record $2.14 billion in 2015–16 to $1.41 billion in 2016–17, according to official sources. Still, the quantity of drugs imported from China remains a significant share of India’s supply.

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