Drug Quality Regulation in India
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Background
Pharmaceuticals form the backbone of the healthcare industry and play a critical role in preventive, curative, and palliative treatments across the world. India in the recent past has emerged as a global pharmacy, catering to the pharmaceutical needs of the world. The challenge, however, lies in ensuring the availability of high-quality and efficient medicines.
About the Study
The objective of this research project was to investigate the regulatory and legislative frameworks that oversee pharmaceutical manufacturing, distribution and consumption in India from an operational point of view, and highlight strengths and weaknesses.
Methodology
The study analyzed India’s pharmaceutical quality regulations from 2005 onward, focusing on:
- Policy documents and CDSCO notifications.
- Literature on policy conception, implementation, and drug types.
- Comparative analysis with U.S. FDA regulations.
- Identification of gaps in enforcement and public awareness.
Key Outcomes
- Regulatory delays and ad-hoc legislation hinder drug quality control.
- Branded generics dominate due to lack of awareness and weak enforcement.
- Implementation suffers from understaffing and overlapping authorities.
- Public education and a central drug quality database are urgently needed.
- International standards (like FDA) positively influence domestic practices.