why medical fraternity can't prescribe Generics ?!

 The directive from the National Medical Commission (NMC) urging doctors in India to prescribe generic medicines ignited a fierce debate, highlighting the complex challenges within the Indian medical system. While the intention behind the directive was to make healthcare more affordable and accessible, the strong opposition from the Indian Medical Association (IMA) and the broader medical fraternity underscores a significant hurdle: a lack of consistent trust in the quality and efficacy of certain generic drugs available in the market. Doctors often express concerns about the bioequivalence of generics from different manufacturers, leading them to favor branded drugs that they believe offer more predictable therapeutic outcomes. This hesitancy, coupled with the perceived responsibility for patient well-being, makes many hesitant to exclusively prescribe generics, even with the potential cost savings.

Following the backlash, the NMC has put its directive on hold, meaning doctors are not currently obligated to prescribe only generic medications.

Generic drugs are pharmaceutical medications that are formulated to be equivalent to their branded counterparts in several key aspects:

 - Dosage

- Strength

- Route of administration

- Quality

- Performance

- Intended use

 These drugs are typically marketed under their chemical name instead of a brand name, which allows for cost-effective alternatives to brand-name medications. The distinction between generic and brand-name drugs lies primarily in branding and marketing; chemically and therapeutically, they are the same.

 

 Historical Context in India

 The Indian government has played a crucial role in the proliferation of generic drugs:

 1. 1960s Initiatives: The government started promoting domestic drug manufacturing.

2. Patents Act of 1970: This act eliminated composition patents for foods and drugs and shortened process patents to five to seven years, enabling local companies to manufacture generic drugs through reverse engineering.

 As a result, India carved out a significant niche in both domestic and international pharmaceutical markets, primarily focusing on producing low-cost medicines.

  Current Market Dynamics

 In the Indian pharmaceutical sector: 

- Brand dominance: Approximately 90% of the domestic market, valued over ₹1,00,000 crore, consists of branded drugs, leading to a scarcity of available generic equivalents.

- Fixed-Dose Combinations (FDCs): Around ₹50,000 crore worth of drugs sold are FDCs, many of which contain multiple active compounds (up to eight or nine).

 This scenario creates challenges:

- Doctors may prescribe medications using their generic names, but pharmacists often push more profitable brands instead of generics.

- The ethical prescribing outlined by the Medical Council of India in 2002, which encourages using generic names, is undermined because patients typically receive the highest-commission product.

Steps Taken by the Government

 1. Jan Aushadhi Scheme: Established pharmacies aim to dispense generic medicines, but their numbers are low (~3,000) compared to over 800,000 retail pharmacies.

 2. Regulatory Proposals: In 2016, the Drugs Technical Advisory Board (DTAB) proposed changes to allow pharmacists to dispense generics against brand prescriptions. However, the proposal was rejected, raised concerns over bioavailability, which measures the extent and rate at which the active ingredient is absorbed and becomes available at the site of action.

Bioavailability vs Bioequivalence

 Bioavailability :  Measure of the amount of a drug that reaches systemic circulation  .                                     

 Bioequivalence: Comparison of the bioavailability of a generic drug with its branded counterpart.                          

Challenges in the Generic Market

 - The bioavailability concerns highlight skepticism regarding the efficacy of generic medications.

- Regulatory doubts indicate possible issues with quality control in the manufacturing processes.

- The inadequacy of public awareness regarding the advantages of generic drugs continues to be a barrier to widespread acceptance.

 Generics are critical for affordable healthcare but face substantial barriers in India, including a dominant brand-name market, regulatory challenges, and pharmacist practices. Government efforts like the Jan Aushadhi scheme show promise but need expansion. Improving awareness and regulation around generic medicines can enhance their market presence and affordability for consumers.