Branded, Generic and the Missing Ingredient of Quality

Why in News?

• Recently, National Medical Commission (NMC) issued a notification asking registered medical practitioners (RMP) to prescribe generic medicines only which led to protests by IMA (Indian Medical Association) and subsequently NMC suspended its notification.
• The withdrawal of the generic prescribing order reflects ongoing complexities in achieving universal healthcare goals and it is important to reflect on challenges in India’s healthcare system, the struggle between generic and brand prescriptions.

Categories of Drugs Being Sold in India

• Branded Under-Patent Drugs
  • Drugs that are developed and marketed by a pharmaceutical company. They are given a brand name by the company, and they are often protected by a patent.
  • When a pharmaceutical company discovers a new drug, they can apply for a patent.
  • A patent gives the company the exclusive right to manufacture and sell the drug for a certain period. During this time, no other company can produce and sell the same drug.
• Branded Generic
  • A branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies’ brand names.
  • These drugs may be less costly than the branded patent version but costlier than the bulk-manufactured generic version of the drugs.
• Generic Drugs
  • Generic drugs have the same active ingredients as their brand-name counterparts. The active ingredient is the chemical substance responsible for the therapeutic effect of the drug.
  • Generic drugs are typically less expensive than brand-name drugs but generic drugs must meet the same quality and safety standards as brand-name drugs.
  • To be approved, a generic drug must demonstrate bioequivalence to the brand-name drug.
    • This means that the generic version must have the same rate and extent of absorption as the brand-name drug.
  • Often it is said that the cost difference is because generic manufacturers do not have the same research and development costs as the original drug company.

Challenges Associated with Generic Medicines

• Restriction on Doctor’s Freedom
  • In India, a salesperson holds the authority to choose the brand of generic medicine for a patient.
  • Doctors are restricted from endorsing specific brands in which s/he has invested his faith in terms of quality.
• False Marketing by Big Pharma Against Generic Medicines
  • The Hathi Committee's 1975 recommendation sought the gradual elimination of brand names.
  • And the belief that only renowned brands guarantee quality is debunked, exposing the influence of big pharma companies with their costly propaganda.
• Ethical Concerns
  • There is a connection between pharmaceutical companies and doctors, leading to unethical marketing practices and kick-backs.
  • In contrast, medical associations, including the IMA, emphasise their ethical commitment to improving patient access to affordable medicines.
• Lack of Quality Assurance and Accountability: A doctor's reputation relies on the reliability of active pharmaceutical ingredients, yet it is not clear who will ensure compliance with quality parameters. 

How Should the Government Address these Challenges?

• Ensure No Compromise on Quality
  • Approximately 4.5% of medicines are fake, and 3.4% are of lower quality, according to two national drug surveys in the last 10 years.
  • These surveys used many samples from pharmacies all over India. To make sure patients are safe and can fully recover, all medicines should pass quality tests 100%.
  • It should be unacceptable if even 5% of medicines do not meet the quality standards.
• Ensure Implementation of Periodic Testing Earnestly
  • The government must ensure the quality of medicines produced, procured, and supplied through its Universal Health Coverage system as well as the private health-care network.
  • For this, there must be periodic lifting of samples for testing. Batches of medicines that fail the quality test must be banned, with punitive action taken against manufacturers.
  • This will eliminate repeat defaulters from the supply chain. The mechanism and systems are in place but are not implemented in earnest.
• Study and Replicate Tamil Nadu’s Practice
  • In TN all supplied medicines are kept under quarantine stock till double blinded samples are cleared in quality testing by government and private sector laboratories.
  • This practice by TN Medical Services Corporation Limited is worth replicating. It is only on receipt of a pass quality test report that stock entry is done.
• Allow Doctors to Prescribe Generic Medicine with Brand Name
  • Until the government can make the assurance (with concrete evidence) that all medicines in the market are of standard quality, doctors should be allowed to use in their generic prescription.
  • The name of the company (in brackets) should be mentioned in which the prescribing doctor has confidence in terms of the quality of the medicine.
• Ensure the Availability Rate of All Essential Medicines above 90%
  • In a study of the availability of 50 essential paediatric medicines in Chhattisgarh in 2010, it was found to be only 17%.
  • Non-essential vitamin tonics and cough syrups line the shelves in a pharmacy but there is no trace of the low profit-margin essential medicines.
  • There must also be a ban on unscientific combinations of medicines; currently constitute around 40% of the retail market in India.
• Expand Janaushadhi Kendras and Effective Implementation of Policies
  • To ensure affordable medicines for all under Universal Health Care, free medicines and free diagnostics are acceptable policy, but implementation needs to be monitored.
  • The network of Janaushadhi kendras needs to be expanded.
• Regulate Profit Margins
  • Approved norms of the profit margin for wholesale agents must be limited to 15%.
  • For retailers it must be 35% over the ex-factory or manufacturer’s selling prices (MSP) excluding transportation cost and VAT.

Conclusion

• Following the IMA’s protest, the NMC has withdrawn the order on generic prescribing. But this is only a case of one step forward but two steps back in moving to the goal of universal access to affordable generic medicines for all without brand names.
• The government needs to bring in reform to address the challenges related to generic medicine because without these comprehensive measures, accessibility to cheaper medicines in India will be a mirage.

Q1) What is the National Medical Commission (NMC)?

The National Medical Commission (NMC) has been constituted by an act of Parliament known as National Medical Commission Act, 2019 which came into force on 25.9.2020 by gazette notification dated 24.9.2020. The Board of Governors in supersession of Medical Council of India constituted under section 3A of the Indian Medical Council Act, 1956 stands dissolved thereafter. The aim of the National Medical Commission is to improve access to quality and affordable medical education, ensure availability of adequate and high quality medical professionals in all parts of the country etc. 

Q2) What is PM Bhartiya Jan Aushadhi Pariyojna?

Under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PM-BJP), approximately 6300 Jan Aushadhi Kendras have been established to provide quality-generic medicines. Launched in 2015 by the department of pharmaceuticals of the Ministry of Chemicals and Fertilisers; Pradhan Mantri Bhartiya Janaushadhi Pariyojana aims to provide affordable healthcare to all.

Source: The Hindu