New Delhi: Small pharma companies can file an online application if they want to take one more year to comply with global good manufacturing practices (GMPs), the Drugs Controller General of India (DCGI) said.
The application has to be submitted through the Online National Drugs Licensing System (ONDLS) portal as no hard copy application will be considered by the Central Licensing Authority.
The government this year extended the timeline for GMP compliance to 31 December, as the previous deadline ended last December. The decision was taken as most of the drug companies could not upgrade their plants to World Health Organization (WHO) standards.
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Micro, small and medium enterprises (MSMEs) with revenue of less than ₹250 crore have to submit an application before the Central Licensing Authority by 11 May along with a plan of upgradation if they wish to seek an extension in the timeline for implementation GMP norms.
This exercise is being done to ensure that medicines manufactured in India are safe and of good quality.
According to the department of pharmaceuticals, the Indian pharmaceutical industry is the world’s third largest by volume and the 14th largest by value. India is globally the largest supplier of generic drugs, accounting for about 20% of the global supply. It manufactures about 60,000 generic drugs across 60 therapeutic categories.
Generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research and manufacturing, biosimilars and biologics are some of the major segments of the Indian pharma industry.
“The Central Drugs Standard Control Organisation (CDSCO) has developed an online system for submitting application through the ONDLS portal. The applicant/manufacturer seeking extension of the timeline has to register on the ONDLS portal and thereafter submit an application. No hard copy of the application for seeking extension of the timeline for implementation will be considered,” DCGI Dr Rajeev Singh Raghuvanshi said in a letter to all pharma industry association, reviewed by Mint.
ONDLS is a single-window platform for online processing of various applications submitted by the applicants for issuance of manufacturing and sales licenses including blood banks, and other certificates like certificate of pharmaceutical product (COPP), GMP, WHO-GMP, market standing certificate, etc., and post-approval changes.
The development assumes importance given that out of India’s 10,000 pharmaceutical companies, around 8,500 are MSME firms which are largely concentrated in Maharashtra, Gujarat, Himachal Pradesh and Andhra Pradesh. Only 2,000 units in the MSME category hold WHO-GMP certification.
GMPs are being implemented in the country to bring quality into products by way of control on materials, methods, machines, processes, personnel and facility or environment.
Queries sent to the health ministry spokesperson remained unanswered.
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