By Arjun Juneja
The pharmaceutical industry is constantly evolving, and the need for quality medicines has never been greater. PM Modi’s clarion call to ‘reform, perform & transform,’ couldn’t have been more opportune, as the pharmaceutical industry in India resets itself with initiatives that could be a game-changer for the country. In recent years, the impetus on drug quality has been underscored, with various Government of India initiatives committed to providing affordable and quality healthcare to all citizens.
Medicines in the USA comply with stringent USFDA’s norms for quality, safety and efficacy and accordingly, India’s quality standards are also being evaluated by US regulatory authorities, for exports to the US, using a common quality benchmark for which a Drug Master File (“DMF”) is to be filed with the application. Pharmaceutical companies in India have taken an initiative to start using DMF quality APIs in the drugs so that it meets the highest standards, enabling access to premium quality medicines at affordable prices for patients across in India.
With DMF quality API, the quality of generic drugs will be up a notch. With increased awareness, patients can be expected to opt for DMF quality drugs because of their international standards.
Comprehending the Term
The significance of a DMF lies in its dual role – confidentiality and regulatory compliance. Though not a strict regulatory requirement, Drug Master File (DMF) has all the information on the manufacturing, stability, quality, packaging, purity and impurity profile of the API, for authorities to ensure that medicines have quality and are efficacious. DMF Quality API is better because it follows stricter cGMP norms and is manufactured at only USFDA-approved plants. It plays a pivotal role in ensuring the quality of drugs.
DMFs facilitate the efficient evaluation of drug products during the approval process. Compliance with Good Manufacturing Practices (‘GMPs’) ensures that products are safe for human use, meet quality control specifications and adhere to regulatory requirements.
Promoting Efficient Drug Manufacturing Practices
Since a DMF can be a complex, time-consuming process, it is important to make sure all information that is included in the DMF remains accurate and updated. With Indian companies now ascertaining and affirming the same quality available to patients internationally, the PM’s call for ‘reform, perform & transform,’ in the medicine industry, may soon be coming true.
(The author is a Chief Operating Officer, Mankind Pharma. Views expressed are personal and do not reflect the official position or policy of the FinancialExpress.com.)
