New Delhi: The government has decided to relax a number of norms on environment clearances related to bulk drug manufacturing to encourage Indian drug makers and reduce the country’s dependence on Chinese imports.

The decision, which was taken in a meeting between the commerce, environment and chemical and fertilizers ministries, comes at a time when the government is working on a bulk drug manufacturing policy.

“I had a meeting with chemical and fertilizers minister Ananth Kumar and environment minister Prakash Javadekar on Tuesday where most of the problems that the bulk drugs manufacturers had raised have been sorted out," commerce and industry minister Nirmala Sitharaman said on the sidelines of the board of trade meeting on Wednesday.

The government has also decided to set up three dedicated parks in the country where special priority will be given to bulk drugs manufacturing, Sitharaman added.

More than 75% of India’s bulk drug imports come from China, according to the department of pharmaceuticals. Bulk drugs or active pharmaceutical ingredients (APIs) are the raw materials used in a drug that gives it the therapeutic effect.

In India, there are 300 large companies and over 10,000 medium and small-scale companies in the bulk drug manufacturing sector. About 77% of them make formulations and 23% APIs.

“We were facing environment hurdles on so many clearances as the country was following age-old rules. We had to get separate clearances for all the drugs from the environment ministry, even if the plant had got a clearance. The government has promised to remove this hurdle and many similar environment related issues," said R.K. Agrawal, general secretary, Bulk Drug Manufacturers Association, an industry lobby group.

The proposed bulk drug manufacturing policy will be based the recommendations made by a committee under former secretary (health research) V.M. Katoch, which has suggested ways to reduce the country’s dependence on Chinese imports.

The panel had suggested steps for the revival of five pharma sector PSUs—Karnataka Antibiotics and Pharmaceuticals Ltd, Rajasthan Drugs and Pharmaceuticals Ltd, Hindustan Antibiotics Ltd, Bengal Chemicals and Pharmaceuticals Ltd and Indian Drugs and Pharmaceuticals Ltd — to start manufacturing select essential critical drugs, like penicillin and paracetamol. The Katoch panel also backed tax-free status and cluster development for the revival of the industry.

Last year, chemicals and fertilisers minister Ananth Kumar told Parliament that India was largely dependent on China for imports of drug ingredients of 12 essential drugs which are in the National List of Essential Medicines.

Sitharaman said this week, “In India, the bulk drugs industry depends on China largely for most of its APIs. So we have been working on it. Now there is an interest for us to set up specified pharmaceutical zones where API manufacturers will be invited to set up units."

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