New Delhi, Anticipating a shortage of key drugs in the country in the wake of the coronavirus pandemic, the government has decided to fast-track environmental clearance process for projects proposing production of bulk drugs in the country.
Accordingly, the Ministry of Environment and Forest office will give projects in respect of bulk drug and bulk drug intermediaries out-of-turn green clearances so that projects could go on stream expeditiously. A ministry office memorandum said the issue has been cleared and will be implemented with immediate effect.
The bulk drug is active pharmaceutical ingredient (API) that goes into manufacturing of formulation and branded 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 completed disrupted this supply.
“This is a welcome development, but it has come too late as setting up bulk drug facilities will take time even for companies in the queue seeking clearances. But, it will certainly help the country to mitigate such risks in future,” said a bulk drug manufacturer not willing to be named.
The government action to facilitate manufacturing of API in the country is in response to calls given by the industry that coronavirus spread may seriously jeopardise the pharna industry in the country leading to shortages of certain key drugs that depend on China for the raw material. Already such shortage is being seen in the case of supplies of Vitamin C pills in the market.
Abhay Pandey, National President, All Food and Drug Licence Holder Foundation (AFDLHF) told IANS earlier that currently, raw material prices of active pharmaceutical ingredients (API) have jumped significantly due to the lock-down in China. Consequently, several domestic companies have stopped producing the drug, which caused a shortage of Vitamin C pills in the market.
“Price control on Vitamin C tablets has kept the cost as low as Rs 5 for 10 pills, so many manufacturers are simply not interested to manufacture this,” Pandey said.
However, Shirish Ghoge, an independent industry expert and a former senior director with Abbott and Sanofi, said the government should first incentivise pharma companies through an ad hoc price increase under the DPCO (drug price control order) in the public interest by NPPA till the situation becomes normal.
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.-Outlook India