Speedy green nod for bulk drugs production

| | New Delhi
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Speedy green nod for bulk drugs production

Friday, 13 March 2020 | PNS | New Delhi

The Centre on Thursday decided to fast-track environmental clearance process for projects entailing production of bulk drugs and bulk drug intermediaries in the country to ensure that it does not have to depend on other nations like China for manufacturing the drugs.

India imports large quantities of bulk drug for its pharmaceutical industry with China alone accounting for over 68 per cent of India''s total imports. Coronavirus has completely disrupted this supply.

The bulk drug is active pharmaceutical ingredient (API) that goes into manufacturing of formulation and branded drugs. However, in a move to ensure that it sufficient bulk drugs is manufactured locally, the Union Environment Ministry on Thursday issued an office memorandum stating that the decision to clear the projects on priority basis will be implemented with immediate effect.

In a notification, the Environment Ministry said the expeditious environmental clearances given to units involving active pharmaceutical ingredients (API) and bulk drug intermediates will ensure overall preparedness and availability of drugs to reduce the impact of the outbreak.

“In order to ensure drug availability/production to reduce the impact of the outbreak of Novel Corona virus (COVID-19) and to improve overall preparedness of drugs, the ministry hereby directs projects or activities in respect of Bulk drugs (API and bulk drug intermediates) shall be considered out of turn and clearances shall be issued expeditiously,” the notification issued by Sharath Kumar, scientist at the ministry’s Impact Assessment division, said.

The notification has been sent to the Central Pollution Control Board, Expert Appraisal Committee and pollution control boards in all states and Union Territories.

The Government has set up a committee to look into the issue of drug shortages coming from trade restrictions in the wake of coronavirus spread. The committee, in its report, has said that the present stock-in-hand of the APIs may be sufficient for 2 to 3 months to manufacture formulations.

India has already restricted export of about 26 APIs and formulations including antibiotics, vitamins and hormones, as the Government explores measures to ensure there is no shortage of drugs in India due to lock-down in China.

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