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GIST OF SANSAD TV : Perspective: Common Drugs Standards

Published: 31st Mar, 2023

Introduction:

Indian pharma companies enabled by their price competitiveness and good quality have made global mark with 60 per cent of the world’s vaccines and 20% of generic medicines coming from India. India ranks 3rd worldwide for production by volume and 14th by value in pharma sector.

Thus the Union Health Ministry in India is considering the formulation of common standards for drug regulations across the country. This is aimed at improving the drug regulation mechanism in India by ensuring consistent implementation of standards and facilitating better monitoring of drug safety. The regulation regarding Common drugs standard is probably a move to trigger by recent deaths globally that were linked to the consumption of drugs manufactured in India.

 

Points of Discussion:

Key Features:

  • Unified national portal: The portal is intended to bring together various drug regulatory functions and processes, currently managed by different government agencies, onto a single platform.
  • Centralized database: It will be used for information related to drugs, manufacturers, and regulatory authorities, as well as a single-window clearance system for drug approvals.
  • Drug safety monitoring: The portal will also include modules for monitoring drug safety and pharma vigilance, and for facilitating online submission of applications for various regulatory processes such as drug approval, clinical trials, and licensing.

Need for Common Standards and Regulations:

  • Huge market potential: India ranks 3rd worldwide for production by volume and 14th by value in the pharma sector.
  • Multiple regulators: The current system is fragmented with 38 drug regulators, each with its own database.
  • Multiple standards: A common set of standards and regulations accepted by both central and state authorities is being worked upon.
  • Easy evaluation: The move could help drug regulators across India know the credentials of all pharmaceutical companies and drugs to be accessed easily.

Benefits

Challenges

  • Easy and regulated application to conduct clinical trials
  • Conducting clinical trials will be scrutinised
  • Application for authorising the marketing of the drug
  • Post-marketing studies
  • India’s federal structure and the fact that healthcare is a state subject.
  • All stakeholders must be involved, including both the Central and state governments must willingly cooperate.
  • Maintaining a central database could be difficult if states do not provide accurate data in a timely manner.
  • Generating awareness and encouraging active participation from all states will take time and effort.

Value addition: 

Timeline for Drug regulation in India:

  • The concept of pharmacovigilance in India was first proposed in 1986 with a formal adverse drug reaction (ADR) monitoring system.
  • The Pharmacovigilance Programme for India (PvPI) was launched on a national footing in 2010 by the Ministry of Health & Family Welfare.
  • In 2016 pharmacovigilance became a mandatory requirement under the Drugs & Cosmetics Act, which was amended to require all manufacturers and importers of medicines to set up pharmacovigilance systems within their companies.

Present Drug Regulation Mechanism in India:

In India, drug regulation is overseen by the Central Drugs Standard Control Organization (CDSCO), a national regulatory body for pharmaceuticals and medical devices. The CDSCO is responsible for regulating the import, manufacture, distribution, and sale of drugs in India.

The following is an overview of the drug regulation mechanism in India:

  • Drug Approval Process: Before a drug can be marketed in India, it must undergo a thorough approval process by the CDSCO. This includes pre-clinical studies, clinical trials, and submission of a New Drug Application (NDA) or a Marketing Authorization Application (MAA).
  • Drug Pricing: The National Pharmaceutical Pricing Authority (NPPA) is responsible for regulating the prices of drugs in India. The NPPA regulates the prices of essential medicines and monitors the prices of non-essential medicines to ensure they are not unreasonably high.
  • Drug Safety Monitoring: The Pharmacovigilance Programme of India (PvPI) is responsible for monitoring the safety of drugs in India. The program collects and analyses data on adverse drug reactions (ADRs) to identify potential safety concerns and take appropriate action.
  • Manufacturing Standards: The CDSCO ensures that drug manufacturers in India adhere to good manufacturing practices (GMP) to ensure that drugs are produced under quality standards and are safe for use.
  • Clinical Trials: The CDSCO regulates clinical trials in India to ensure that they are conducted ethically and with the safety of participants in mind. The CDSCO requires that clinical trials follow the guidelines of the International Conference on Harmonization (ICH).

 

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