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Generic Medicine in India

Generic medicines in India are pharmaceutical drugs that are bioequivalent to brand-name drugs but sold under their chemical name or a non-proprietary name at significantly lower prices. The Indian pharmaceutical industry is a major producer of generic drugs globally, and their use is actively promoted by the Indian government to improve healthcare affordability and accessibility.

History

India's focus on generic drug production can be traced back to the Patents Act of 1970, which allowed for process patents rather than product patents. This allowed Indian companies to reverse-engineer existing drugs and produce them at lower costs. This policy played a crucial role in developing India's robust generic drug manufacturing sector. In 2005, India amended its patent laws to comply with the TRIPS Agreement,[1] reintroducing product patents. However, provisions like compulsory licensing and pre-grant opposition have been used to ensure continued access to affordable medicines.[2]

Regulatory Framework

The regulatory framework for generic medicines in India is primarily governed by the Drugs and Cosmetics Act, 1940,[3] and the Drugs and Cosmetics Rules, 1945.[4] The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority responsible for approving new drugs, setting quality standards, and regulating the manufacture, import, and sale of pharmaceuticals, including generics. Generic drugs must demonstrate bioequivalence to their brand-name counterparts through bioequivalence studies before they can be marketed.[5]

Government Initiatives Promoting Generic Medicines

The Indian government has implemented several initiatives to promote the use of generic medicines:

Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP)[6]

This scheme aims to make quality generic medicines available at affordable prices through dedicated outlets called Jan Aushadhi Kendras.

National Health Mission (NHM)[7]

The NHM supports the provision of essential generic drugs free of cost in public health facilities.

National Medical Commission (NMC) Regulations[8]

The NMC mandates that physicians prescribe medicines using generic names.

Challenges

Despite the government's efforts, several challenges remain:

Doctor Perceptions and Prescription Practices[9]

Some doctors continue to prefer prescribing branded drugs due to various factors, including marketing by pharmaceutical companies and perceived differences in quality.

Public Awareness and Trust

Many patients may have misconceptions about the quality and efficacy of generic medicines.

Ensuring Quality and Bioequivalence

Maintaining consistent quality and ensuring bioequivalence of generic drugs is crucial for public confidence.

Supply Chain and Distribution

Effective supply chain and distribution networks are essential to ensure the availability of generic medicines, especially in rural areas.

Impact

The widespread availability of generic medicines in India has had a significant impact on healthcare affordability and access, particularly for low-income populations. It has also contributed to the growth of the Indian pharmaceutical industry.

Future Directions

Continued efforts are needed to address the existing challenges and further strengthen the generic medicine sector in India. This includes:

  • Strengthening regulatory oversight and quality control.
  • Enhancing public awareness and trust in generic medicines.
  • Improving supply chain and distribution networks.
  • Promoting rational use of medicines by healthcare professionals.

See also

References

  1. ^ "Agreement on Trade-Related Aspects of Intellectual Property Rights". World Trade Organization. Retrieved 2023-10-27.
  2. ^ [[invalid URL removed] "Compulsory Licensing under the TRIPS Agreement"]. World Trade Organization. Retrieved 2023-10-27. {{cite web}}: Check |url= value (help)
  3. ^ [[invalid URL removed] "The Drugs and Cosmetics Act, 1940"]. Central Drugs Standard Control Organization. Retrieved 2023-10-27. {{cite web}}: Check |url= value (help)
  4. ^ [[invalid URL removed] "The Drugs and Cosmetics Rules, 1945"]. Central Drugs Standard Control Organization. Retrieved 2023-10-27. {{cite web}}: Check |url= value (help)
  5. ^ Food and Drug Administration. [[invalid URL removed] "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA"]. U.S. Department of Health and Human Services. Retrieved 2023-10-27. {{cite journal}}: Check |url= value (help)
  6. ^ Template:Cite wikipedia
  7. ^ "National Health Mission". Ministry of Health and Family Welfare, Government of India. Retrieved 2023-10-27.
  8. ^ "The National Medical Commission Act, 2019" (PDF). Retrieved 2023-10-27.
  9. ^ "Explained: Why doctors opposing govt's directive on prescription of generic medicines". Business Today. Retrieved 2023-10-27.
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