India must self-sufficient in APIs & Drugs: Experts

India is highly depending on China for 75% requirement of bulk-drugs and drug intermediates, and also highly depending on fermentation based drugs.

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It is high time for government of India and for the healthcare management authorities in the country thought about a strong remedial measure for the pharmaceutical manufacturing industry to survive any possible crisis that may occur because of the grim situation that China, a dependent source of bulk drugs for India, confronts today.

India is highly depending on China for 75% requirement of bulk-drugs and drug intermediates, and also highly depending on fermentation based drugs. If import of fermentation based drugs is halted, production and availability of antibiotics will come to a standstill.

So, India should consider all ways to manufacture the country’s requirement for all APIs without leaving a chance to depend on any foreign country. The situation created by the outbreak of coronavirus infection in China (COVID-19) teaches that lesson, according to industry leaders and policy experts.

The Indian pharmaceutical sector needs to be self-reliant and self-sufficient in the production and availability of all kinds of formulations as well as all categories of bulk drugs and drug-intermediates.

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Today the whole world depends on China for import of active pharmaceutical ingredients (APIs). Once that country stops its foreign sale of drug intermediates, domestic production of many drugs may be halted in every country, observes Dr. PV Appaji, pharma industry policy expert and former director general of Pharmaceutical Export Promotion Council of India (Pharmexcil).

According to him, about 75% of API requirements for drug manufacturing are coming from China alone. It includes mostly bulk drugs and drug intermediates for making all essential drugs. Moreover, India is extremely dependent on China for fermentation based drugs. Pencilin, amoxicillin, azithromycin, cephalosporin..etc are imported from China.

“We have sufficient technology to manufacture all these APIs. About 25 years ago, five companies in India started manufacturing fermentation based drugs for local requirements. But soon China reduced the prices of their products and accordingly Indian companies could not withstand the situation.

Very soon they had to close down their factories because of no government support. If government protects the manufacturers, they will produce all the required APIs here. 6-Aminopenicillanic acid (6-APA) and 7-aminocephalosporanic acid (7-ACA) are important intermediates for manufacturing antibiotics.

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These are produced from penicillin and cephalosporin which are imported to India in intermediate forms. If their supplies are stopped, the situation will affect the production of antibiotics in India. Same will be the situation in those countries which are depending on China also”, says Dr. Appaji.

Dr. Viranchi Shah, president of Gujarat State Board of the Indian Drugs Manufacturer’s Association (IDMA) has responded that government of India should take steps with the industry to manufacture sufficient quantity of bulk drugs needed in the country.

“This is a short term crisis as we feel now, but industry has an inventory of raw materials for next two months. If the crisis continues for a long term and supplies are not coming from China, the situation will hit Indian pharma sector”, he said.

He, however, said the government has already started discussion with industry leaders for escalating production of bulk drugs. If proper support is given to Indian industry, 50% of the requirement can be made in India and gradually the dependence on China on APIs can be reduced.

According to SV Veeramani, former president of the IDMA, all the companies have a stock of APIs for next two months and the situation in China has started improving. The factories there have reopened after their holiday due to China New Year. Corona infection has affected in the city of Wuhan only. But he said government has called industry leaders for discussion about API production.

When contacted J Jayaseelan, chairman of TN IDMA, he said at present the situation created due to COVID-19 has not impacted supplies to India from China. But there is a slight increase in the prices of some products imported from China. However, import is continuing.