ET Impact: DCGI asks pharma cos to adhere to production quality standards

New Delhi: The Drugs Controller General of India (DCGI) has issued an advisory stating 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 parameters of quality, safety and efficacy.

The DCGI's move comes a few days after ET reported that industrial excipients are used in manufacturing medicines and over 50 companies manufacturing cough syrups have failed quality tests. The World Health Organization (WHO) said in October last year that the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug manufacturer.

"In order to ensure quality, safety and efficacy of drug formulation, it is of paramount importance that such formulations are manufactured in compliance with the prescribed standards not only in respect of API (active pharmaceutical ingredient) but also various excipients used for manufacturing of the formulations. Therefore, the quality, safety and efficacy of both APIs and the excipients are crucial," according to the advisory.

In the case of cough syrups, as various critical excipients like propylene glycol, glycerine, sorbitol, etc. are used, the drug regulator said companies are required to ensure that the excipients meet the regulatory norms on quality to avoid contamination in the formulations produced from such excipients.

"In view of above, the manufacturers are hereby advised that they should purchase and use only pharma grade excipients from their approved sources/vendors which are of quality standards in accordance with the regulatory requirements under the provisions of the said Act & Rules to ensure quality, safety and efficacy of the drug formulations," the advisory said.

The DCGI's advisory gains significance as the ongoing winter season tends to see increased use of cough syrups in the country.

In a separate note, DCGI Rajeev Singh Raghuvanshi referred to quality concerns reported for propylene glycol (PG) supplied to cough syrup manufacturers.