India to push for local manufacturing of APIs, reduce dependence on China
New Delhi: In a bid to reduce India’s dependence on China for active pharmaceutical ingredients (APIs), the chemicals and fertilizers ministry has joined hands with other ministries to draw up a road map for increasing their production in the country.
Bulk drugs or APIs are the active raw materials used in medicines to give them their therapeutic effect.
A high-level task force has been constituted to study global practices and draw up a plan aimed at boosting domestic production of APIs, an 18 April memorandum issued by the chemicals and fertilizers ministry stated.
The task force, headed by minister of state Mansukh L. Mandaviya, will include secretaries from the departments of pharmaceuticals and industrial policy and promotion, the ministry of health and family welfare, and the ministries of environment, commerce and biotechnology.
The director general of the Council of Scientific and Industrial Research, and the Drug Controller General of India, along with one member from each of the pharma lobby groups and experts from the private sector, will also be part of the group which is expected to formulate a road map to revive India’s API sector with “implementable recommendations”.
“The specific areas of focus may include research and development, acquisition and commercialization, development of the industry, regulatory framework, potential impact on the industry, investments, contribution to the economy, exports, integration with value chains etc,” the memorandum said.
Currently, over 60% of APIs are sourced from other nations; for some specific APIs, the dependence is over 80-90%, according to the department of pharmaceuticals.
“India continues to rely on imports of key starting materials, intermediates and APIs from China, with the share of dependence increasing over time. This potentially exposes us to raw material supply disruptions and pricing volatility,” a study released by the Federation of Indian Chambers of Commerce and Industry in February said.
Some pharma experts feel that this is a futile exercise as the government already has enough information on the subject. To attain self-sufficiency in bulk drugs and reduce dependence on China, the government had earlier set up a panel headed by the then director general of Indian Council of Medical Research, V.M. Katoch, in 2013. The committee submitted its report in 2015.
“Even that report is gathering dust. Government should have looked into the recommendations and implemented them. This committee looks like another futile exercise. The committee consists of bureaucrats instead of experts from the API industry,” said Chinu Srinivasan, coordinator, All India Drug Action Network, a group of healthcare-focused NGOs.
D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), which represents 20 of the country’s biggest drug makers, said the government should not delay action any further.
“The government has enough information. Apart from the Katoch committee report, there are two more reports. Action is very clear but instead of taking action, they are busy constituting one committee after another. It’s (a) critical time and the government must assure timely action instead of wasting time on constituting committees,” he said.
However, chemicals and fertilizers minister Ananth Kumar feels the government has intervened at the right time. “The government has accepted many of the recommendations of the Katoch committee and proceeded with the action plan. India will not only catch up in APIs but will start competing with other countries,” he said.