August 13,2024
The Central Drugs Standard Control Organization (CDSCO) has directed makers of sterile equipment to comply with Schedule M of the Drugs and Cosmetic Rule, which mandates companies to follow Good Manufacturing Practices (GMP) at par with the World Health Organization (WHO) standards.
Till now, GMP has been compulsory for only drug makers but compliance is regarded as equally important for sterile product and vaccines makers. The development assumes significance given the growing size of the Indian sterile equipment market.
“The revised GMP notification which was published last December is generally for all types of pharmaceutical items. It prescribes general requirements that need to be followed by all the pharmaceutical firms. The notification clearly specifies the requirements for each type of product such as sterile products, biologicals, ophthalmic solutions and other injectables etc.,” said an official.
“In addition to the general requirements, WHO publishes their guidelines from time to time for various products. Companies have been told to do the self-assessment, take necessary steps to fill the gaps and strengthen GMP compliance as per WHO standards,” said the official mentioned above.
These products include surgical equipment, forceps, biopsy equipment, eye equipment including soft contact lenses, eye solutions, arthroscopes, and laparoscopes and injectables which directly goes into the bloodstream of the patient.
Good Manufacturing Practices, or GMP, as mandated by the WHO, prescribes essential standards to enhance product quality through control measures related to materials, methods, machinery, processes, personnel, facilities, and the environment.
The government, last year in December, had amended or revised the Schedule M of the Drugs and Cosmetics Rules, 1945 to upgrade, tighten and make GMP norms mandatory, especially for micro, small and medium enterprises (MSMEs).
As part of the government’s guidelines, which were announced in July 2023 and notified in December 2023, pharma companies with annual turnovers of over ₹250 crore were to compulsorily follow GMP within six months, while those with a turnover of less than ₹250 crore were supposed to do so over a 12-month period.
Compliance of GMP guidelines was made stronger to ensure the quality standards of drugs being manufactured in India after the Central government’s risk-based inspection of pharmaceutical firms found serious lapses at the manufacturing site such as infrastructural deficiencies, poor documentation, under-skilled employees, absence of testing of raw material etc.
This was done in the backdrop of Indian cough syrups causing the deaths of children in Gambia and Uzbekistan.
“This is with reference to revision of schedule M and WHO good manufacturing practices for sterile pharmaceutical products, which are published by WHO from time to time. In this regard, it is requested that all manufacturers should take necessary steps for compliance with respect to various requirements as per the guidelines after due gap analysis,” said DCGI in a communication on 7 August to all sterile and vaccine manufacturers.
Aniket Dani, Director-Research, CRISIL Market Intelligence & Analytics said, “As per the latest available data, the domestic vaccines market size stood at about Rs. 1,700 crore for fiscal year 2024. This segment contributed about 1% of the overall domestic formulations market.”
Rajiv Nath, Forum Coordinator of AiMeD (Association of Indian Medical Devices Industry) said that the market for medical sterile medical devices may be over $ 4-5 billion.
Meanwhile, the government is continuously conducting risk-based assessment of these pharmaceutical companies Health minister J.P. Nadda recently stated in Parliament that in the last one year the government had conducted risk-based inspections of 400 pharma companies to check if they are following GMP rules.
As a part of the inspection, more than 300 show cause notices, stop production order, suspension, cancellation of licences have been issued.
Source: Drugs Control