12 Sep

Generic Medicines

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Contents

• What is a Generic Drug?
• Government’s attempt in promoting generic drugs
• Advantages
• Limitations

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What is a generic drug?

• Generic drug is a low cost version of pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended use.
• They usually enter market after patent protection of the original drug expires.

Branded Generics

Even after expiration of patents, drugs are made available under certain brands and are called branded generics.

Government’s attempt in promoting generic drugs

• Making it mandatory for all chemists to display generic medicines prominently
• Medical Council’s code of conduct advises generic prescriptions by doctors as part of their duties and responsibilities. MCI has issued a circular saying doctors to face disciplinary action if they prescribe brand name drug.
• Pradhan Mantri Bhartiya Janaushadhi Pariyojna (PMBJP) was launched by Department of Pharmaceuticals, Ministry of Chemical and Fertilizers, Government of India as a direct market intervention scheme in 2008.
  • As of Jan 2023, 9,000 Jan Aushadhi Kendras are functional across the country.
    • The government has set up a target to increase the number of Jan Aushadhi Kendras to 10,000 by March 2024.
      • It offers 1759 medicines, and 280 surgical devices covering all major
        therapeutic groups.

Advantages

1. Affordable healthcare

• Products sold as unbranded generic medicines are cheaper than the branded medicines.
  • It doesn’t include manufacturer’s marketing cost, cost spent on prescribing
    doctors.
• Various studies have shown that high out of pocket expenditure is pushing a lot of families into poverty.

2. Breaks the doctor-pharma nexus

• Presently, doctors and pharma companies have a nexus under which doctors prescribe only the brand of companies giving them some king of advantages.

3. Reduce unnecessary prescription

• This is resorted to by doctor if pharma companies are paying them

4. Promotes domestic pharma companies

• As India is a world leader in generic drug manufacturing, promoting it would further improve the growth of domestic pharma sector.

5. Difficult for quacks to function

• They might not even know the generic names

Limitations

1. Quality concerns

• There are concerns about lack of uniformity in the quality of generic versions
• Clinical practices have shown than many generic versions don’t work.
• Doctors trust the popular, visible and multinational brand more.

2. Erode doctor-patient relationship

• As by prescribing generic drugs, doctor refuse to take responsibility for clinical outcomes.

3. Low profit margins for retailers

• Retails pharmacists, in turn, have little incentive in stocking and selling low price generic medicines since they have lower profit margins.

4. Shortage

• Availability of generic medicines have faced shortage. Even the few Jan Aushadhi stores that have been opened since 2008 have not been able to continuously supply these medicines regularly.
• Still, 90% of the Indian pharmaceutical needs are fulfilled by the branded versions.

5. Difficult for common person to understand

• Salt names, especially for FDCs will be difficult for common people to understand.

6. May discourage big pharma companies to launch their new medicines in India.

Way forward

• Increasing production and availability
  • Government should ensure more Jan Aushadhi kendras to ensure easy availability and accessibility of generic medicines before taking any such decision.
• Improving regulations of pharma sector
  • Currently, ensuring the quality of drug is a problem in the absence of adequate regulations and shortage of drug inspectors and lab facilities to check drug quality.
  • There is a shortage of drug quality inspectors with only about 18,00 inspectors for the entire country.
• Allow pharmacist to substitute for alternative: Laws for enabling substitution of generic and branded equivalents by pharmacists need to be introduced.
• No Branding for out of patent drugs
  • Medicines out of patent should not be allowed to be sold in branded form.
• Increased awareness on generics needed among consumers, pharmacists
• Short names for generic FDCs.
  • Briefer officially approved trade names for all rational fixed dose combinations so that doctors do not have to painfully write out the generic names of their multiple constituents
• Improving government health facilities
  • We also need a fully functioning health system with free healthcare for all like in UK, Canada and Scandinavian countries is needed.

Conclusion

• Overall, generic prescribing is a good move in the right direction and will have several positive ramifications for healthcare in India. However, like everything, successful implementation would require a series of enabling steps at different levels from production to prescription and from Quantity to Quality.

Example Questions

• “Generic medicines can play a key role in making India’s health sector affordable”. Discuss. [15 marks, 200 words]