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With the aim of maintaining the confidence of global health regulators in medicines made in India, the center is working to tighten good manufacturing practices followed by Indian pharmaceutical companies, News18.com has learned.
Based on the proposal from the Ministry of Commerce and Industry, the Ministry of Health and Family Welfare is working on updating Schedule M of the Medicines and Cosmetics Act 1940.
The idea is to bring manufacturing standards on par with the World Health Organization’s Good Manufacturing Practice (GMP) standards. The Department of Health and Family Welfare is working on revising the schedule along with the Drug Administration (DoP) – an arm of the Department of Chemicals and Fertilizers.
The move has significance as India has faced numerous allegations by global regulators, including pollution complaints from Gambia, Uzbekistan, the United States, the Marshall Islands and Micronesia. Some of these claims were highlighted by a WHO drug alert which raised questions about the quality of Indian drug products.
“The Ministry of Commerce and its pharmaceutical export arm Pharmixil have proposed the Ministry of Health to tighten good manufacturing practices across India and implement Schedule M,” an official from the Ministry of Commerce and Industry, familiar with the development, told News18.com.
“The Department of Commerce has asked the Department of Health to take an important step because it is necessary to send a strong message to global health regulators that India is fixing the problems,” the official said, adding, “It is time for India to come to an end.” He needs to work on retaining the trust of the regulators and actions will speak better than mere words…”
Another Health Ministry official confirmed that the government is working to stabilize Schedule M again.
What is table m?
Schedule M of the current Code addresses Good Manufacturing Practices for buildings, materials, plant and equipment requirements. It also contains details about quality control systems, quality control laboratories, equipment cleaning, housekeeping and cross contamination among others.
In 2018, Schedule M was revised in conjunction with the Center’s plan to implement uniform standards for the pharmaceutical manufacturing industry prior to joining the Pharmaceutical Inspection Collaboration System (PICS), a global mechanism for improving GMP collaboration between regulators. PICS compliance helps boost pharmaceutical exports because it provides greater market access and also makes it easier for global regulators to trust the quality of medical products.
However, later, the updated draft of the prepared schedule was not implemented.
“While the law was updated in 2018, it has not been implemented. Once approved, the scope of GMP regulatory requirements will be double what it is today,” said the official quoted above.
Once approved, the government will make following the WHO-GMP mandatory for all pharmaceutical companies, including those that produce medicines for domestic use as well as for export. Currently, only exporting companies follow WHO-GMP standards.
A series of complaints has damaged India’s reputation
On April 25, the World Health Organization issued a Medicinal Product Alert regarding a batch of substandard (contaminated) Guaifenesin TG syrup located in the Marshall Islands and Micronesia. The cough syrup is manufactured by QP Pharmachem in Punjab and marketed by Haryana-based Trillium Pharma and has been proven to contain toxic chemicals.
In February, Delhi-based healthcare company Global Pharma recalled all lots of artificial tear-lubricating eye drops in the United States after 55 reports of adverse events, including eye infections, permanent vision loss, and death from bloodstream infection.
In January, Uzbek authorities complained about a cough syrup made in India that had led to deaths among children, while in October the World Health Organization issued a warning about another cough medicine exported and manufactured by India that had led to the death of several children. in Gambia.
While in the case of Gambia, India has denied allegations of contamination, in other cases either investigations are underway or the company has been found guilty and suspended manufacturing.
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