Shore up supply of critical drugs, govt tells pharma industry
New Delhi: The Department of Pharmaceuticals (DoP), during a meeting on Wednesday, urged pharma companies to strive for self-sufficiency in critical drugs like penicillin, rifampicin and insulin, in a sign of government concern over India’s dependence on Chinese imports.
A large number of so-called active pharmaceutical ingredients (APIs), or bulk drugs, that go into manufacturing 15-20 drugs, such as antibiotic penicillin and anti-diabetic metformin in the National List of Essential Medicines, are imported from China.
According to industry experts, there are no domestic producers left for a number of drugs like Penicillin G, making India dependent on imports for key intermediates used in essential antibodies.
“We are dependent on China for penicillin, which is the mother antibiotic for all the third-generation antibiotics. China has about 80% of the penicillin market. Likewise, rifampicin, which is the backbone for (treatment of) TB (tuberculosis), there is only one unit in India...The government has to take stringent steps to ensure that over-dependence on China even for essential drugs is curtailed,” said an industry expert who spoke on the condition of anonymity.
The meeting organized by the DoP on Wednesday was attended by representatives of the Indian Drug Manufacturers’ Association (IDMA) and the Federation of Pharma Entrepreneurs (FOBE), along with executives from Glenmark Pharmaceuticals Ltd, Intas Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd, Pfizer Ltd, Cipla Ltd, Aurobindo Pharma Ltd as well as Sun Pharmaceutical Industries Ltd.
The DoP has proposed providing financial assistance for revamping old manufacturing facilities, refurbishing plants and machinery and ensuring subsidized supply of electricity and sugar for making production of penicillin at internationally competitive prices.
In its agenda for the meeting, the department also suggested financial assistance to local manufacturers—both in the public and private sectors—for the procurement of the latest technical knowhow (including appropriate strains of microbes) for economic production of penicillin.
For the local manufacturing facilities that have closed down due to substantially cheaper imports, the department proposes to offer pro-active incentives to revive their plants.
The department has also proposed consultations with the department of biotechnology and the ministry of health and family welfare to address the technological aspects of producing insulin through biotechnological interventions, according to the agenda reviewed by Mint.
A second industry expert said Indian drug makers were unable to compete with Chinese API producers, who enjoy the support of the Chinese government in terms of reduced excise duty, availability of finance and cheap power.
“The Indian government should be serious about the issue. We just hope that this meeting should reap some results. Any breakdown in the supply of APIs from China could seriously impact the country and the patients. This is a question of national security and we must act soon,” this person said, also on condition of anonymity.
In the draft pharmaceutical policy, the department has proposed restrictions on the import of active pharmaceutical ingredients and suggested setting up of mega bulk drug parks to boost domestic production.
The government has also proposed that formulations produced with indigenous active pharmaceutical ingredients be given preference in government procurement.