The Department of Pharmaceuticals (DoP) has introduced a novel approach to control the pricing of drugs that have lost their patent protection. According to the new mechanism, the retail price of an off-patent drug will be established at half of the existing maximum price once the patent has expired. This ceiling price will be subject to review after a year, using market data. This topic is crucial for students preparing for the IAS exam.

Non-Patent Drug Cost Control Mechanism - UPSC Notes | Testbook.com
Decoding the Non-Patent Drug Cost Control Mechanism:
- The Department of Pharmaceuticals recently issued a notice detailing the new method for determining ceiling prices for off-patent drugs.
- The price calculation for the ceiling price will exclude the innovator brand and any of its licensee partner brands.
Why is it Significant?
- This development is particularly important given the recent expiration of patents for several key diabetes drugs.
- The Department of Pharmaceuticals has held meetings with industry representatives and stakeholders to discuss this matter.
Pricing Mechanism and the Creation of a Predictable Pricing Regime:
- As per industry experts, the maximum price of a combination drug, such as glimepiride and pioglitazone for diabetes, will be half the price of glimepiride.
- The price of pioglitazone in combination will be 20% less than the current highest price.
- The highest price will undergo a review after one year.
- This approach will make drug pricing more predictable for consumers and manufacturers alike.
The Advantages of a Pricing Mechanism for Off-Patent Drugs:
- Industry insiders believe this new pricing mechanism for off-patent drugs will be beneficial for all kinds of treatments, not just for diabetes medication.
- This will be a significant benefit for consumers.
National Pharmaceutical Pricing Authority (NPPA) and the Price Cap on Off-Patent Anti-Diabetes Drugs:
- The National Pharmaceutical Pricing Authority (NPPA) capped the prices of anti-diabetes drugs after Glimepiride's patent expired last year.
- In a subsequent move, the NPPA set the prices of these two drugs to range between Rs 10-20 per tablet in August.
- It is expected that Vildagliptin, a drug produced by Novartis, will lose its patent in the upcoming year.
About the Indian Patents Act, 1970:
- The Indian Patents Act is a legal framework that was enacted by the Indian Parliament in 1970 to regulate the country's patent system.
- The Act governs the granting, usage, and revocation of patents for inventions.
- It defines the prerequisites and conditions for granting patents, such as originality, non-obviousness, and industrial applicability.
- The Act also provides for compulsory licensing of patents under specific circumstances to ensure public access to essential medicines and other important inventions.
Related Links | |||
Counterfeit Drugs | Drug Price Control Order | ||
Medical Devices Under Drugs Law | Active Pharmaceutical Ingredients (APIs) | ||
Patent Act 1970 | Intellectual Property Rights |
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