The pharmaceutical industry is constantly evolving, and the need for quality medicines has never been greater. Prime Minister Modi's clarion call to 'reform, perform, and transform' couldn’t have been more opportune, as the Indian pharmaceutical industry resets itself with initiatives that could be a game-changer for the country. In recent years, the emphasis on drug quality has been underscored, with various Government of India initiatives committed to providing affordable and high-quality healthcare to all citizens.
Medicines in the USA comply with stringent USFDA norms for quality, safety, and efficacy. Consequently, 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 required to be filed with the application.
As one of India's leading pharmaceutical companies, Mankind Pharma has taken the initiative to incorporate DMF quality Active Pharmaceutical Ingredients (APIs) in its drugs. This ensures that the company meets the highest standards, enabling access to premium quality medicines at affordable prices for patients across 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.
Drug Master Files (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 creating a DMF can be a complex and time-consuming process, it is crucial to ensure that all the information included in the DMF remains accurate and up-to-date. With Indian companies now confirming and affirming the same quality available to international patients, the Prime Minister's call for 'reform, perform & transform' in the pharmaceutical industry may soon become a reality.