With the increasing import of active pharma ingredients (API) from China affecting the domestic bulk drug industry and impacting cost factors of formulations, the Department of Pharmaceuticals (DoP) has sought stern measures including anti-dumping duty on API imports from China.

The DoP is learnt to have taken up the matter with the Ministry of Commerce for imposing anti-dumping duty. However, the Commerce Ministry is still studying the matter and a decision would be taken up after analysing all related aspects, sources said.

According to the DoP, almost 40 per cent APIs are imported from China into India which also has affected the growth of bulk drug industry in the country. If the import is made on low prices, the formulations would be cheaper and consumers will be benefited.

“If China increases the prices, it would be a problem. A balance has to be created. The matter was taken up with the Commerce Ministry in detail, seeking the possibility of imposing anti-dumping duty on imports of APIs,” sources said.

Commerce Ministry on its part has suggested critical policy interventions and special efforts to increase the presence of Indian pharma industry in China and reversing the trend in active pharmaceutical ingredients sector.

“Interestingly, CAGR (compound annual growth rate) of pharma exports to China over the last five years has been recorded at –6.44 per cent. This is extremely embarrassing for the Indian industry. It is noteworthy that at one point of time in the recent past India produced more than 70 per cent of its bulk drugs. Today, it produces only 30 to 40 per cent. Most of its bulk drugs come from China. Thus, a large part of Indian exports is formulation of Chinese bulk drug. This is an extremely disappointing and critical aspect of Indian pharma industry,” according to the Commerce Ministry.

“Action is required at two levels. First of all, critical policy interventions need to be made in the API sector for bringing back bulk drug manufacturing to India. This would require concerted government action over the next few years. Secondly, special efforts need to be made to increase India’s presence in China in the formulation sector. This could be negotiated as part of an understanding between India and China. India should also negotiate with China cooperation in the regulatory and enforcement area. This is an extremely sensitive area, therefore, cautious and calibrated approach would be required,” the Ministry said.