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 to promote 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.
- Affordable healthcare
- Breaks the doctor-pharma nexus
- Reduce unnecessary prescription
- Promotes domestic pharma companies
- Difficult for quacks to function
- 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.
- Erode doctor-patient relationship
- As by prescribing generic drugs, doctor refuse to take responsibility for clinical outcomes.
- 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.
- 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.
- Difficult for common person to understand
- Salt names, especially for FDCs will be difficult for common people to understand.
May discourage big pharma companies to launch their new medicines in India
- 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.
- 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.
“Generic medicines can play a key role in making India’s health sector affordable”. Discuss. [15 marks, 200 words]