Study attempts to find out how India made diabetes medicines affordable

Why in the News

A study titled “Making Modern Diabetes Medications Affordable and Accessible: Lessons from India for Other Countries”, published in the journal Diabetes Care, sets out how India brought down the prices of new and expensive diabetes drugs and asks what of that is transferable to other low and middle income countries (LMICs), where 80% of the world’s 589 million adults with diabetes live. The study was led by the chairman of a Chennai diabetes specialities centre. It attributes the price fall to a legislative history of safeguards against “patent evergreening”, a large generic and biosimilar manufacturing base, competitive entry by domestic manufacturers, and public distribution through Jan Aushadhi Kendras. The tension is that the two drug classes India has made cheapest sit outside the National List of Essential Medicines (NLEM), so the price fall rests on market competition rather than on any entitlement, and the study records that rural availability, generic quality and pharmacovigilance remain unresolved.

What is “patent evergreening”?

1. The practice: Evergreening is the extension of a monopoly on a drug by patenting a minor variation of a known molecule, such as a new salt, polymorph or dosage form, once the original patent nears expiry.
2. The statutory safeguard: Section 3(d) of the Patents Act, 1970 denies a patent to a new form of a known substance unless it demonstrates enhanced therapeutic efficacy, which closes that route.
3. Why it decides price: Blocking a second monopoly on the same molecule lets generic manufacture begin at patent expiry, and it is generic entry that produces the price fall.

Where does the world’s diabetes burden actually sit?

1. The distribution: Of the 589 million adults living with diabetes worldwide, 80% are in low and middle income countries, which is why an Indian pricing experience is being read as a template.
2. The modern therapies: GLP-1 receptor agonists and SGLT2 inhibitors, meaning sodium glucose cotransporter 2 inhibitors, improve cardiovascular and renal outcomes, while analogue insulins reduce the risk of hypoglycaemia.
3. Why affordability is the binding constraint: Diabetes requires lifelong care and the management of complications, so the cost is recurring rather than one time, and a price that is merely high becomes prohibitive over a lifetime.

What brought modern diabetes drug prices down in India?

1. The export base: India’s ability to maintain low medication prices is closely linked to its role as a major pharmaceutical exporter, which gives domestic manufacturers scale independent of the domestic market.
2. Generic manufacture as a legal choice: The safeguards preventing evergreening were paired with a legislative framework permitting generic manufacture of drugs, and that combination is what the study identifies as strategic.
3. Competitive entry: Initial uptake of the newer drugs was constrained by pricing, and the price of semaglutide in India dropped considerably after multiple domestic manufacturers entered, followed by a large increase in sales.
4. Quick generic and biosimilar availability: Rapid availability of generic and biosimilar versions is what converts patent expiry into an actual price movement rather than a nominal one.
5. Public distribution: Deliberate regulatory and distribution strategies, principally the Jan Aushadhi Kendras, supply generics through a parallel retail channel at controlled prices.

What has the state done on raw materials and manufacturing?

1. The dependency being addressed: Concerns persist over global trade policies affecting both prices and the availability of raw materials, which is the upstream input a domestic formulation industry cannot substitute quickly.
2. The incentive scheme: A government incentive scheme was introduced to promote domestic manufacturing of raw materials rather than of finished formulations alone.
3. The result so far: As of 2025, production has commenced for 26 molecules that were previously imported.

What does the essential medicines list still leave out?

1. What is listed: Metformin and the sulfonylureas continue to form the foundation of type 2 diabetes management in India, and both are included in the National List of Essential Medicines.
2. What is not: DPP-4 inhibitors, meaning dipeptidyl peptidase 4 inhibitors, SGLT2 inhibitors and GLP-1 receptor agonists have all been introduced in India but none of them is currently in the list.
3. Why the gap matters: Inclusion in the list is what brings a formulation under a ceiling price, so the newer classes are cheap because manufacturers compete rather than because a ceiling requires it.

Challenges to India’s affordable diabetes medicine model

1. Rural availability lags the price fall: Distribution and availability of medicines differ sharply between urban and rural India, so a lower price at the counter does not reach a patient without a stockist nearby. Eg. The newer injectable therapies need a cold chain that rural retail pharmacies typically do not maintain.
   The Fix: Route the newer diabetes therapies through the public cold chain already built for the immunisation programme rather than through retail alone.
2. Quality varies between generic versions: Differences in quality between generics of the same molecule undercut the substitution on which the entire price strategy depends. Eg. The Central Drugs Standard Control Organisation publishes monthly lists of drug samples declared not of standard quality.
   The Fix: Publish batch level bioequivalence data for every approved generic of a newer diabetes molecule, so substitution rests on evidence rather than on price alone.
3. Pharmacovigilance depends on voluntary reporting: Maintaining strict pharmacovigilance is difficult at the scale at which these molecules are now dispensed, so adverse effects of newly cheap drugs go unrecorded. Eg. The Pharmacovigilance Programme of India, run by the Indian Pharmacopoeia Commission, relies on prescribers choosing to file adverse event reports.
   The Fix: Make adverse event reporting mandatory for the institutions dispensing the newer drug classes, with a fixed filing window.
4. Price control does not reach unlisted molecules: A formulation outside the essential medicines list escapes ceiling pricing and is subject only to the annual cap on price increases. Eg. Non scheduled formulations may raise prices by up to 10% a year under the Drugs (Prices Control) Order, 2013.
   The Fix: Add the newer classes to the essential medicines list once domestic competition makes a ceiling price sustainable for manufacturers.
5. Tight regulation weighs against innovation: The same regulatory density that keeps prices low reduces the incentive to develop a new molecule domestically, so the model depends on molecules first developed elsewhere. Eg. Indian manufacturers compete largely on generic and biosimilar versions of originator drugs rather than on new chemical entities.
   The Fix: Separate the approval pathway for a genuinely new molecule from the generic approval pathway, with a defined review timeline.
6. Scheme performance is measured by outlets, not outcomes: Formal evaluation of the government schemes for their long term impact on clinical outcomes is limited, so the programme can report reach without reporting effect. Eg. Distribution schemes report the number of outlets and the value of medicines sold rather than glycaemic control among their buyers.
   The Fix: Link dispensing records at public outlets to a glycaemic outcome registry, so the scheme is judged on control achieved.

Conclusion

India’s experience suggests that affordability in a chronic disease is produced by legal design and market structure together, not by a price order alone. What remains unresolved is that the arrangement delivers cheap medicines without guaranteeing them: the classes with the steepest price falls carry no listing that would hold those prices if competition thinned. For the other low and middle income countries the study addresses, the transferable part is the patent standard and the generic manufacturing base, and neither can be adopted in isolation from the other. The measure to watch is whether the newer drug classes enter the National List of Essential Medicines at the next revision.

Back2Basics: Jan Aushadhi Kendras

1. What they are: Jan Aushadhi Kendras are dedicated retail outlets that sell quality generic medicines at prices well below those of branded equivalents.
2. Who runs them: The scheme sits with the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers, and is implemented through the Pharmaceuticals and Medical Devices Bureau of India.
3. Its history: The campaign was launched in 2008 and was relaunched in 2015 as the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP).
4. What it stocks: The outlets carry generic medicines across therapeutic categories along with surgical and consumable items, sourced from suppliers holding the required quality certification.

Matching Previous Year Question

“How is the government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?”