"Study Explains How India Cut Diabetes Drug Prices"
Section 3(d)
Patents Act provision barring patents on known-substance variants without enhanced efficacy.
NLEM
National List of Essential Medicines, the government's list of price-controlled essential drugs.
India's affordable-medicines model rests on a specific legislative history. The Patents Act, 1970 originally recognised only process patents for pharmaceuticals. This let Indian companies reverse-engineer drugs and build a strong generic industry. When India joined the World Trade Organization and had to comply with the TRIPS Agreement, the Patents (Amendment) Act, 2005 reintroduced product patents. But it also added Section 3(d), a safeguard that blocks patents on new forms of known substances unless they show significantly enhanced therapeutic efficacy. This provision was tested in the Novartis AG v. Union of India case in 2013. The Supreme Court refused a patent for the cancer drug Glivec, ruling that a minor molecular change did not meet the efficacy bar. This judgment is widely seen as the legal foundation that keeps India's generic drug industry open, even for molecules still patented elsewhere.
Alongside patent policy, India built a separate system to keep prices low and medicines accessible. The National List of Essential Medicines (NLEM) identifies medicines whose prices are capped under the Drug Price Control Order (DPCO), 2013, enforced by the National Pharmaceutical Pricing Authority (NPPA). The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) runs Jan Aushadhi Kendras that sell unbranded generic medicines at low prices across the country. India is already one of the world's largest producers of vaccines, statins and antiretroviral drugs, supplying a large share of the global market for HIV medicines. This existing export capacity in generics is what allowed the same competitive-manufacturing model to bring down prices of newer diabetes drugs.
Type 2 diabetes treatment in India still rests on metformin and sulfonylureas, both included in the NLEM. Metformin lowers glucose mainly by reducing glucose production in the liver. Sulfonylureas work by stimulating the pancreas to release more insulin. Newer drug classes, DPP-4 inhibitors, SGLT2 inhibitors (SGLT2i) and GLP-1 receptor agonists (GLP-1 RA), work differently. SGLT2i block glucose reabsorption in the kidney, so excess glucose is excreted in urine. GLP-1 RA mimic gut hormones that boost insulin release, slow digestion and reduce appetite. …
Consider the following statements regarding Section 3(d) of the Patents Act, 1970:
1.It prevents the patenting of a new form of a known substance unless it shows significantly enhanced therapeutic efficacy.
2.It was invoked by the Supreme Court of India to deny a patent for the cancer drug Glivec.
Which of the statements given above is/are correct?
Which of the following statements about India's drug price regulation is/are correct?
1.The National Pharmaceutical Pricing Authority fixes ceiling prices for medicines included in the National List of Essential Medicines.
2.All diabetes medicines available in India, including newer drug classes, are covered under the National List of Essential Medicines.
Select the correct answer using the code given below:
Match List I (Diabetes drug class) with List II (Mechanism of action) and select the correct answer using the code given below:
List I:
A.Metformin
B.Sulfonylureas
C.SGLT2 inhibitors
D.GLP-1 receptor agonists
List II:
1.Stimulate pancreatic insulin secretion
2.Block renal glucose reabsorption
3.Reduce hepatic glucose production
4.Mimic gut incretin hormones
The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) is primarily aimed at:
The government's Production Linked Incentive (PLI) scheme for bulk drugs primarily aims to:
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