1 day Ago By Sumi Sukanya Dutta
New Delhi: The government Saturday proposed to extend the timeline by a year for adopting Good Manufacturing Practices (GMP) norms for small and medium scale drugmakers across India which have been under scrutiny for producing substandard medicines. ThePrint has learnt that this proposed extension in adopting Schedule M of the Drugs and Cosmetics Act and Rules for companies with an annual turnover of under Rs 250 crore comes mainly at the behest of Laghu Udyog Bharti, a Rashtriya Swayamsevak Sangh-backed organisation. The deadline for adopting GMP norms for these companies had ended on 31 December, 2024.
But in a draft notification issued Saturday, the Union Health Ministry proposed that these firms can now complete the process by 31 December, 2025, and within the next three months, they will need to submit a complete gap analysis and upgradation plan. The draft notification is set to be notified finally after a week. There are nearly 10,500 drug manufacturing units in India, of which nearly 8,500 fall into medium and small scale enterprises while 2,000 are already complied with the World Health Organization (WHO) GMP standards.
Nearly 4,500 of these units have an annual turnover of over Rs 250 crore and they had a deadline to adopt the Schedule M by 29 June, 2024, as per the government’s guideline for this category of companies. Viranchi Shah, president of the Indian Drug Manufacturers’ Association (IDMA), the network of India’s small and medium scale generic drugmakers, called the step a major relief for nearly 4,000 drugmakers who were looking at an uncertain future due to the deadline. “This decision will help the companies who have the intent to adopt Schedule M but had been unable to do so by the earlier deadline due to lack of resources and time,” he told ThePrint.
The idea, Shah said, had been to push the companies to upgrade, rather than shutting them down. Another senior IDMA member, who wished to not be named, told ThePrint that while the associations of pharmaceutical companies had been pushing for the extension, the government relented mainly when Laghu Udyog Bharti weighed in. “There were a few meetings with senior health ministry officials and representatives of the organisation recently and it committed on behalf of the drugmakers,” said the member.
A senior office bearer of Laghu Udyog Bharti, too, confirmed this. ThePrint reached Union health secretary Punya Salila Srivastava via email. This report will be updated if and when a response is received.
In a statement issued Saturday, the ministry said that representations had come from various industry associations representing pharma MSME sector for extension of the deadline. “The main reasons for seeking extension are arranging for financing for upgradation and time for implementation of the required changes,” it added. Also read: ICMR proposes testing of TB at village level in revised national essential diagnostics list Schedule M of the Drugs and Cosmetics Act, 1940, deals with GMP for pharmaceutical manufacturing units, including specific requirements pertaining to premises, plant and equipment.
GMP are mandatory standards which build and bring quality into product by way of control on materials, methods, machines, processes, personnel and facility or environment etc. GMPs were first incorporated in Schedule M in 1988. The norms were last amended in December 2023, bringing GMP recommendations and compliance expectations at par with global standards, specially to those of WHO and to ensure production of globally acceptable quality of drugs.
However, before the latest amendment in mid-2023, then Union Health Minister Mansukh Mandaviya set a deadline for all drug manufacturers to mandatorily adopt GMP norms. This decision followed a series of high-profile incidents involving quality concerns among Indian drugmakers over the preceding year. These included small- and medium-scale drugmakers exporting drugs—mainly cough and cold syrups—to countries in Africa and Asia, as well as major companies exporting generic drugs to countries such as the US.
These episodes prompted the apex drug regulator along with state drug Controllers to initiate risk-based inspections of drug manufacturing firms from December 2022. Last month, the government informed the Parliament that as part of the initiative, risk-based inspections of more than 500 premises have been conducted so far. “Drug manufacturing firms have been identified based on risk criteria like number of drugs declared as not of standard quality, complaints, criticality of the products etc,” said a written reply by the ministry in Rajya Sabha.
It further informed that based on findings of inspections, more than 400 actions—like issuance of show cause notices, stop production orders, suspensions, cancellation of licenses and product licenses—have been taken by the state licensing authorities, in accordance with the provisions of the Drugs Rules, 1945. But the government Saturday said that the latest observations from the units being audited and the feedback coming from stakeholders clearly shows the “improvement on ground towards implementation of GMP standards by MSMEs.” “This augurs well for production of safe, efficacious and quality pharmaceuticals and drugs in the country,” the government also said.
It further pointed out that the department of pharmaceuticals has launched a scheme—Revamped Pharmaceutical Technology Upgradation Assistance Scheme—to provide financial support for the upgradation of MSME units. (Edited by Zinnia Ray Chaudhuri) Also read: Govt says no plan to ban heartburn drug ranitidine, carcinogenic impurities within safe limits var ytflag = 0;var myListener = function() {document.removeEventListener('mousemove', myListener, false);lazyloadmyframes();};document.
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