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Generic and the Missing Ingredient of Quality

Context:

In India, numerous patients opt for a second opinion at a pharmacy, seeking advice from the seller rather than a qualified pharmacist. Individuals with basic reading abilities, regardless of educational background, interpret doctor’s prescriptions and provide information on medicines.

Relevance:

GS2- Health

Mains Question:

What are impediments in access to affordable yet effective medicines in India? What can be done to make the pharmaceutical sector more patient-centric? (15 marks, 250 words)

Concerns associated with the field of pharmaceuticals in India and suggested way forward:

Relying on the Seller of Medicines:

  • This practice, often performed by non-pharmacists, involves queries about the strength, purpose, and potential side effects of medications.
  • Responses are typically offered free of charge under the condition that the prescribed medicines will be purchased from the same pharmacy.
  • The prescription, regardless of being issued by renowned specialists such as cardiologists, neurologists, or gastroenterologists, is unquestionably accepted based on the advice provided at the medical shop.
  • Interestingly, the same individual tends not to inquire about the health risks of alcohol consumption or the potential development of conditions like fatty liver, cirrhosis, and liver failure at a bar counter or liquor shop.
  • Similarly, they do not seek information from the personnel at a cigarette shop regarding the impact of smoking on their lungs and the risk of cancer.
  • In supermarkets, customers often overlook the insecticide coating on vegetables and fruits, rarely questioning the availability of safer alternatives.

Generic v/s Branded:

  • This is the situation in India’s over-the-counter sales, where a salesperson holds the authority to determine the brand of generic medicine (pharmacological compound) to be provided to a patient.
  • The prescribing doctor is restricted from specifying their preferred brand, in which they have confidence regarding quality.
  • On August 3, 2023, the National Medical Council (NMC) issued a directive requiring doctors to prescribe only generic names, leading to protests.
  • The avoidance of brand names is due to the perceived high costs associated with many brands, while generic names are more economical.
  • In 1975, the Hathi Committee advocated for the gradual elimination of all brand names. The notion that only certain renowned and branded companies maintain quality is a misconception perpetuated by prominent pharmaceutical companies, employing expensive propaganda and unethical marketing techniques.
  • There is a suspected collaboration between pharmaceutical companies and doctors, potentially leading to unethical practices such as accepting marketing incentives, promotions, or kickbacks.
  • However, the Indian Medical Association and affiliated professional organizations of specialists assert that enhancing access to affordable medicines is part of their ethical commitment to patients.
  • The success and reputation of a doctor in providing effective treatment rely on the reliability of the quantity and quality of the active pharmaceutical ingredient present in a tablet, syrup, or injection available at a pharmacy.

Quality of Drugs:

  • Ensuring 100% quality-tested drugs is imperative for patient safety, as even a 5% failure rate is deemed unacceptable.
  • The government is urged to implement stringent quality control measures, including periodic sampling and testing, banning substandard batches, and taking punitive actions against defaulting manufacturers.
  • Adopting the approach of the Tamil Nadu Medical Services Corporation Limited could be beneficial. In this practice, all medications supplied are placed in quarantine stock until double-blinded samples undergo clearance in quality testing conducted by both government and private sector laboratories. Only upon receiving a positive quality test report is the stock officially entered.
  • In the absence of concrete evidence ensuring the standard quality of all medicines in the market, some advocate allowing doctors to include the name of the trusted pharmaceutical company in their generic prescriptions.
  • This proposal aims to maintain quality control until the government can assure the market’s overall adherence to quality standards.

Other Concerns:

Additional concerns include the availability of essential medicines, unscientific combinations of medicines, and the need for monitoring the implementation of policies promoting free medicines and diagnostics under Universal Health Care. To achieve affordable medicines for all, measures like expanding Janaushadhi kendras, limiting profit margins for wholesalers and retailers, and banning unscientific medicine combinations are deemed necessary.

Conclusion:

Following protests by the Indian Medical Association, the NMC withdrew the order on ‘generic prescribing’ on August 23, 2023. However, this move is viewed as a step backward in achieving universal access to affordable generic medicines without brand names.


December 2024
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