Regulators receive 1,000 applications from MSME drugmakers for good manufacturing practice compliance
With the deadline for filing an application ending on May 11, applications that fail to meet the criteria will lead to measures including displaying factors notifications, production orders, suspensions and even cancellation of licenses.
In 2023, the government notified the revised timetable M of the Drugs and Cosmetics Act of 1945 to be comparable to the World Health Organization (WHO) pharmaceutical company standards.
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In the first phase, drug manufacturers’ annual turnover ₹People with 25 billion and above will be compulsory to follow GMP within six months, while smaller companies will be one year.
MSME manufacturers must fully implement GMP by December 31. However, they should submit a recommendation to the central licensing authority by November 11 to explain its upgrade plan.
The questions sent to the spokesperson of the Ministry of Health were not answered until the time of publication.
It is worth noting that India is tightening its scrutiny due to alleged contamination, domestically manufactured drugs failed to conduct quality testing overseas. For example, cough syrup, allegedly made by Indian companies, is linked to child deaths in developing countries including the Gambia and Uzbekistan, including the Gambia and Uzbekistan, in 2022 and 2023.
GMP compliance will ensure that the drugs produced in domestic factories are safe, quality and efficacy.
Players around the world
This is important because the Indian pharmaceutical industry is a major global player and the largest supplier of generic drugs, accounting for about 20% of the global supply. It produces about 60,000 generic brands in 60 treatment categories. According to Pharmexcil regulations, India’s pharmaceutical exports were $30.47 billion in fiscal 24, the government’s agency to promote the export of pharmaceutical products.
The Central Drug Standards Control Organization (CDSCO) has developed an online system, the Online National Drug Licensing System (ONDLS), a portal for drug manufacturers to submit applications.
“The government requires all pharmaceutical companies to improve their quality. CDSCO has received about 1,000 applications from the company. The company has submitted an upgrade plan. The government is now checking the application,” the first official said.
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In the days leading up to the May 11 deadline, Union Health Minister Punya Salila Srivastava also attracted the attention of the review meeting, highlighting that few companies have submitted their applications to DCGI.
“However, based on the available data, few companies have submitted applications for an extension of the implementation schedule,” the Health Minister said in a letter to the state and union territorial government.
The Health Secretary directs all national drug regulators and drugmakers to prioritize GMP for the prescribed time period and submit an application for extension on the ONDLS portal.
“We have sent consultations to companies in our jurisdictions as directed by the Minister of Health,” said an anonymous drug controller.
Deadline extension
“All major associations require an extension to submit an application. The deadline for May 11 has ended and those who submit an application will be extended to implement the GMP by December 31, 2025, and those who do not apply mean that they have complied with the rules and regulations. Strict action will be taken for non-compliance with compliance officers.”
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Last year, the Alliance government introduced the remodeled Pharmaceutical Technology Upgrade Assistance Program (RPTUAS) to help pharmaceutical manufacturers upgrade their manufacturing units. Under the plan, the government provides financial assistance to companies to upgrade their factories to meet global standards.
“There are two situations: First, many companies follow GMP compliance, and second, some companies may not be able to raise funds and may close. Multiple reminders are issued by governments related to GMP. We are also sensitive to our member companies following GMP.”
Key Points
- The Indian Pharmaceutical Director received 1,000 applications from MSME medical manufacturers detailing their plans to adhere to good manufacturing practices by the December 31 deadline.
- Companies that fail to meet GMP standards may cease production, suspend licenses or cancellations.
- India has amended bills on drug manufacturing to implement who are standard GMP practices.
- The Central Drug Standards Control Organization has developed an online national drug licensing system to simplify GMP applications.
- The Health Minister raised concerns that many companies were unable to submit their applications, and the Drug Association asked for a deadline.
