October 5th 2023.
The pharmaceutical industry is changing rapidly and the need for quality medicines has never been greater. Prime Minister Modi has given the clarion call of 'reform, perform, and transform' in order to make the Indian pharmaceutical industry a game-changer. The Government of India has taken various initiatives to provide access to affordable and high-quality healthcare to all citizens.
The USFDA has set stringent quality, safety, and efficacy norms for medicines in the USA, and these standards are also being applied to India for exports to the USA. To meet these standards, a Drug Master File (DMF) needs to be submitted along with the application.
Mankind Pharma, one of India’s leading pharmaceutical companies, has taken the initiative to incorporate DMF quality Active Pharmaceutical Ingredients (APIs) into its drugs. This ensures that the company meets the highest standards, enabling access to premium quality medicines at affordable prices for patients across India.
The inclusion of DMF quality APIs in generic drugs creates a common quality benchmark for international standards. This should also lead to increased awareness among patients, who will be able to opt for DMF quality drugs due to their superior quality.
The significance of a DMF lies in its dual role of confidentiality and regulatory compliance. It contains all the information on the manufacturing, stability, quality, packaging, purity and impurity profile of the API, which is used by authorities to ensure that medicines are both safe and efficacious. DMF Quality API is better because it follows stricter cGMP norms and is manufactured at USFDA-approved plants.
Creating a DMF is 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, Prime Minister Modi's call for 'reform, perform & transform' in the pharmaceutical industry may soon become a reality.
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