Schedule a Call Back
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)
Related Stories
Process Equipment
Manufacturing approval granted for three indigenous Mpox testing kits
These RT-PCR kits, which utilise fluid samples from pox rashes to detect the virus, were validated by the Indian Council of Medical Research (ICMR).
Read moreProcess Equipment
Pharma firms ask for December 2026 as extension for implementation of rules
Schedule M of the Drugs and Cosmetics Rules, 1945, outlines good manufacturing practices (GMP) for pharmaceutical products, including a prompt recall system for defective products.
Read moreProcess Equipment
DCGI introduces guidelines for product traceability in pharma supply chain
The introduction of these guidelines is particularly timely, as the Indian pharmaceutical industry has come under scrutiny following reports linking spurious cough syrups from India to children's de..
Read moreRelated Products
Programmable Controllers - Pcd-33a Series
CHEMICAL PROCESS, FOOD/PHARMA EQUIPMENT & ANALYTICAL INSTRUMENTS
Pro-Med Instruments (P) Ltd offers a wide range of programmable controllers - PCD-33A Series.
Gasket Graphite Powder
CHEMICAL PROCESS, FOOD/PHARMA EQUIPMENT & ANALYTICAL INSTRUMENTS
Arihant Packing & Gasket Company offers a wide range of gasket graphite powder.
Asahi Kasei expands 3D printing filament sales in North America
CHEMICAL PROCESS, FOOD/PHARMA EQUIPMENT & ANALYTICAL INSTRUMENTS
Asahi Kasei, a leading resin and compounding technology provider, has initiated the sales of 3D printing (3DP) filaments in North America through Asahi Kasei Plastics North America (APNA). The soft la Read more
latest News
Subscribe to iNoW
For Industry News on WhatsApp, Give a Miss Call on: +91 84228 74016
