On Generic medicines – Branded, generic and the missing ingredient of quality

Source: This post on generic medicines has been created based on the article “Branded, generic and the missing ingredient of quality” published in The Hindu on 17^th November 2023.

UPSC Syllabus Topic: GS Paper 2 Social Justice – Issues relating to development and management of Social Sector/Services relating to Health.

News: This article discusses the issues with prescribing generic medicines without appropriate quality checks. It also highlights reforms needed to ensure access to affordable medicines in India.

Recently, the National Medical Council (NMC) directed all doctors to prescribe only generic names instead of brand names, which led to protests. The NMC has since withdrawn the order.

What are generic medicines?

A generic drug is a pharmaceutical drug that contains the same chemical substance (active pharmaceutical ingredient (API)) as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire.

It may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.

What are the allegations against big pharmaceutical brands?

1. High Costs: Many brands are costly. Generics are relatively more affordable.
2. Unethical practices by big pharma: According to the 1975 Hathi Committee, branded companies propagate the myth that only they have good quality through propaganda and unethical marketing techniques.
3. Nexus between Pharma companies and Doctors: This alleged nexus can indulge in unethical marketing and promotional offers or kick-backs.

What are the challenges associated with generic medicines?

1. Underqualified Pharmacists: In over-the-counter sales in India, an underqualified salesperson can decide the brand of generic medicine to be given.
2. Doctor’s Vast Experience negated: The prescribing doctor has no freedom to mention a brand in which he has invested his faith in terms of quality.
3. Lack of Quality Compliance: There is a lack of coordination between manufacturers, networks of pharmaceutical industries and price control authorities in ensuring quality compliance.
4. Prevalence of Substandard Drugs: The prevalence rate of spurious and “not standard quality” medicines, stands at 3-4%. Drugs must be 100% quality test-passed.
5. Profit Considerations: The underqualified chemist or sales boy at the retail store may decide the generic brand primarily on the basis of profits to be gained, and not the best one.

What should be done?

No Compromise on Quality: The government must ensure the quality of medicines produced, procured, and supplied. For this, there has to be periodic lifting of samples for testing.
TN Case Study: All supplied medicines are kept under quarantine till double blinded samples are cleared in quality testing by government and private sector laboratories.

Allow Recommendation of Generic Brand: Till such time as the government is able to ensure quality, doctors should be allowed to use the name of the company of confidence.

What are some other reforms which can improve access to affordable medicines in India?

1. Tackling Availability of Essential Medicines: The availability rate of all essential medicines must be above 90%. However, there is a lack of availability due to low profit margins.
2. Banning Unscientific Medicine Combinations: There must also be a ban on unscientific combinations of medicines.
3. Expanding the network of Janaushadhi Kendras: To ensure affordable medicines for all under Universal Health Care, free medicines and free diagnostics are required. For this, the network of Janaushadhi kendras needs to be expanded.
   More on Janaushadhi Yojana here.
4. Fixing Profit margins: Approved norms of the profit margin for wholesale agents and retailers must be limited to a fixed percentage.

Question for practice:

An increased focus on Generic medicines can bring down the cost of healthcare in India, however, it is not without its challenges. Elaborate.