Govt extends helping hand to boost API production

This will also help the country avoid supply constraints of active pharmaceutical ingredients (API) and intermediates.

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Govt
Govt of India
3 min. read

Concerned over API supplies getting badly hit from China with pandemic corona virus outbreak, the government has extended a helping hand to drug industry to make the country self-reliant in bulk drug production.

This will also help the country avoid supply constraints of active pharmaceutical ingredients (API) and intermediates

At a meeting, Niti Aayog chief executive officer Amitabh Kant called upon the industry captains to become internationally competitive in API production and go for a global scale of operations.

He assured that the government of India will take all necessary steps to support the API industry in its endeavours. 

The meet was attended by secretaries from the Department of Pharmaceuticals (DoP); Ministry of Environment, Forest and Climate Change; Department of Health Research; and senior officers from the Department of Expenditure, Department of Chemicals and Petrochemicals, NITI Aayog and CDSCO, captains of the pharma industry, including Dr Kiran Majumdar Shaw (Biocon), Dr Pankaj Patel (Zydus), Dr Satish Reddy (Dr Reddy Laboratories), and senior officers of Sun Pharma, Aurobindo, Jubliant Life Sciences, Cipla, Mylan, Alembic, Themis, presidents of Bulk Drug Manufacturers Association (BDMA), Indian Drug Manufacturers Association (IDMA) and Indian Pharmaceutical Alliance (IPA) etc.

Also read: Drug industry to strictly comply with UCPMP: DoP

They deliberated on various measures to decrease dependence on China for APIs and intermediates. Some of the measures include not to have any capping on increase in the API production if load of pollution is going to be same or less.

At present the pollution control board permits only 50 per cent increase. Besides this, the industry is also looking at category wise permission instead of product wise permission by pollution control board. 

At present there are key 60 APIs supplied to India from Chinese territories like Henan, Hubei, Guangdong, Hunan, Wuhan, Zhejaing in China. 

Some of key APIs which are essential include acarbose, ambroxol HCL, aminoacids various, amoxicillin trihydrate, azithromycin, biotin, calcium butyrate, calcium pantothenate, ibuprofen, ciprofloxacin HCL, florfenicol, ofloxacin, paracetamol, marbofloxacin, vitamin A, vitamin B complex, vitamin E, D3 etc.

The government aims to build capacity for these APIs. 

India which was ahead in China in API production in 1990s lost its position due to free land, low cost utilities such as water, steam, power offered by China to its API industry. 

Now, the government has taken a keen interest in promoting bulk drug parks in the country with an aim to make India a powerhouse in key starting materials, intermediates and APIs.

Meanwhile, the ministry of environment and forest has assured fast clearances to bulk drug park proposals. “The government wants to set up and revive the bulk drug industry, build capacity and expedite environmental clearances,” said an officer.

Principal secretary (industry), government of Telangana, explained various incentives offered by state government and invited the industry to set up manufacturing units in Hyderabad Pharma City. 

Meanwhile, companies facing delays in supplying drugs to hospitals run by central and state governments as per the contract due to supply chain constraints in the wake of coronavirus outbreak in China will not face any penal action, stated a memorandum sent by the finance ministries to all ministries.

Earlier, representatives of drug industry urged the minister of state for health Ashwini Choubey not to take penal action or blacklist the manufacturers failing to execute government contract in a timely manner.

The DoP is also looking to ban export of 12 APIs and formulations to overcome their shortage amidst coronavirus outbreak following recommendation of a task force set up by the department under chairmanship of Drugs Controller General of India (DCGI) recently to deal with repercussions of coronavirus outbreak on supply of Chinese APIs in India.

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