DCGI prescribes guidelines for pharma companies

The Drugs Controller General of India (DCGI) Rajeev Raghuvanshi proposed an advisory for pharma companies to strictly abide by conditions stated in their manufacturing licences and prescribed Good Manufacturing Practices (GMP) to ensure that the products meet quality, safety and parameters.

12 Dec 2023 | By Aditya Ghosalkar

Advisory: Importance of adhering to standards for API and excipients

Under the Ministry of Health and Family Welfare (MoHFW), the Drugs Controller General of India (DCGI) leads the Central Drugs Standard Control Organization (CDSCO). In the amendment to the 83-year-old Drugs and Cosmetics Act of 1940, the DCGI is responsible for approving licenses for specified drug categories in India. It played a crucial role in approving the Covid-19 vaccines recently.

On 22 February 2023, the Centre appointed Rajeev Raghuvanshi as the new DGCI. Secretary-cum-scientific director at the Indian Pharmacopoeia Commission, Raghuvanshi represents a pharmaceutical background with expertise in dosage form design and development.

In a recent advisory, Raghuvanshi proposed that pharmaceutical companies are required to strictly abide by conditions stated in their manufacturing licences and prescribed Good Manufacturing Practices (GMP) to ensure that the products meet quality, safety and parameters.

The functional requirements of drugs essentially cover adherence regarding active pharmaceutical ingredients (API) and the excipients used in their formulation. In the case of cough syrups which comprise excipients such as propylene glycol, glycerine, and sorbitol, the companies must avoid contamination in such formulations.

Quality control

The DCGI oversees the quality control of pharmaceutical products, and this extends to the packaging materials. The packaging must meet regulatory standards to prevent contamination, ensure product stability, and maintain the integrity of the drug.

Raghuvanshi points out at quality concerns reported for propylene glycol (PG) supplied to cough syrup manufacturers. 

In regard, the advisory mentions that the manufacturers should purchase and use only pharma-grade excipients from their approved sources, vendors which are of quality standards by the regulatory requirements.

Labelling requirements

The Legal Metrology Act, 2009 and Legal Metrology (Packaged Commodities) Rules, 2011 provide for the standardisation of packaging and labelling in India and define the labelling requirements of all commodities manufactured, imported and sold in the country.

Raghuvanshi emphasises the inclusion of briefing of the pharmaceutical product, given the harmful side-effects of which can pose a threat to human life. The labelling and packaging information should provide accurate and clear details including dosage instructions, warnings, and other relevant information.

Abidance result

When drug companies comply with the standards, it enables them to stand true on the regulatory front including inspections and audits of pharmaceutical manufacturing and packaging processes.

With the onset of the winter season, the DCGI's advisory gains significance.

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