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CDSCO mandates GMP compliance for sterile equipment manufacturers
Industry News- Aug 14,24
This move marks a significant shift, as GMP compliance was previously required only for drug manufacturers.
The Central Drugs Standard Control Organization (CDSCO) has directed manufacturers of sterile equipment to adhere to Schedule M of the Drugs and Cosmetics Rules, aligning with Good Manufacturing Practices (GMP) standards as outlined by the World Health Organization (WHO). This move marks a significant shift, as GMP compliance was previously required only for drug manufacturers.
The inclusion of sterile equipment under GMP guidelines is crucial given the expanding Indian market for these products. The new regulations aim to ensure higher quality standards for various sterile items, including surgical instruments, forceps, biopsy tools, eye equipment, and injectables.
“The revised GMP notification published last December covers all pharmaceutical items and specifies requirements for different product types, such as sterile products, biologicals, and ophthalmic solutions,” an official explained.
In addition to general requirements, companies must now follow WHO guidelines, regularly conducting self-assessments and addressing compliance gaps to meet international standards.
The government had previously revised Schedule M of the Drugs and Cosmetics Rules in December 2023 to tighten GMP norms, particularly impacting micro, small, and medium enterprises (MSMEs). According to the guidelines announced in July 2023, companies with annual turnovers exceeding Rs 2.5 billion must comply within six months, while those with lower turnovers have a 12-month period.
This update follows a government inspection revealing significant GMP lapses, including infrastructural issues and poor documentation. This action is partly in response to incidents involving Indian cough syrups linked to child deaths in Gambia and Uzbekistan.
In a communication dated August 7, the Drug Controller General of India (DCGI) urged all sterile and vaccine manufacturers to undertake necessary steps for compliance based on the revised guidelines and conduct gap analyses.
According to CRISIL Market Intelligence & Analytics, the domestic vaccine market was valued at approximately Rs 17 billion for FY 2024, representing about 1% of the overall domestic formulations market. Rajiv Nath from the Association of Indian Medical Devices Industry (AiMeD) estimates the market for sterile medical devices could exceed $4-5 billion.
The government continues to conduct risk-based assessments of pharmaceutical companies, with over 300 enforcement actions taken in the past year, including show cause notices, production stoppages, and license suspensions.
Queries to the health ministry spokesperson remain unanswered.
(Mint)
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