Summary:
India is developing national quality standards for semaglutide as domestic pharmaceutical companies prepare to enter the growing generic weight loss drug market. The Indian Pharmacopoeia Commission is working on a monograph to standardise quality testing and manufacturing requirements. The framework could improve product quality and reduce testing costs, while increasing compliance requirements for smaller pharma companies.
India is set to devise a national quality framework for semaglutide, which is the key ingredient in many of the most popular diabetes and weight loss drugs, as local manufacturers seek to enter the lucrative market for generic versions of the medication.
The Indian Pharmacopoeia Commission (IPC) has started developing a pharmacopoeial monograph for semaglutide, which will detail the legally binding quality tests that need to be conducted before a pharmaceutical can be marketed as a semaglutide-based drug. Currently, manufacturers are relying on internal controls and/or follow international guidelines.
Why India Needs Standards for Semaglutide
Semaglutide is a glucagon-like incretin hormone analogue peptide used in various medications that target the regulation of blood sugar and satiety centers in the brain. Unlike regular tablets, peptides require highly specific manufacturing processes involving amino acid chains.
India has become a major player in the market for semaglutide-based medications, being the only country to have multiple manufacturers interested in entering the market at once. These manufacturers are using different production methods to make their respective versions of semaglutide, including traditional peptide synthesis and cellular expression of the protein using recombinant DNA technology.
The draft of the monograph will serve as a reference for both state drug controllers and manufacturers. It will enable officials to check if a given sample of semaglutide is properly manufactured and not counterfeit while also standardizing the testing procedures used by manufacturers. By providing an in-country reference, India will also be able to reduce the cost of semaglutide-related testing by promoting the use of domestically produced materials.
The Centre has identified semaglutide as a priority for inclusion in the upcoming Indian Pharmacopoeia Addendum 2028.
The Rising Demand for Weight Loss Medication in India
India is set to see a significant rise in demand for weight loss medications as the patent for semaglutide expires on 20 March this year. Analysts predict that the Indian market for semaglutide-based drugs will be worth over USD 347 million by 2035. Domestic manufacturers have already started positioning themselves for their share of the market.
Most of the companies that have announced plans to launch semaglutide-based drugs or are currently testing their formulations are targeting their medications against the dominant foreign competitors, such as Ozempic and Wegovy. The companies have launched or are planning to launch drugs branded as Semaglyn, Semasize, Obeda, and others, using doses of semaglutide to indicate the strength. The cost of these medications in India varies significantly depending on the manufacturer and dosage, but the price range is approximately between 1,300 and 16,400 Indian Rupees (INR) per month for similar treatments.
Besides developing semaglutide-based medications, India has also seen a rise in other weight loss treatments, such as Orlistat and Tirzepatide.
Impact on the Market and Pharmaceuticals Sector
The implementation of India’s national framework for semaglutide medications will have a major impact on both domestic and international pharmaceutical companies. It will standardize the production process, bringing local manufacturers in line with international competitors. At the same time, it will also increase the barriers to entry for new firms as they will have to invest significantly in quality control to meet the requirements.
The new standards are likely to benefit both India’s domestic pharmaceutical sector and international companies that want to enter the Indian market. By establishing reference materials, India will reduce the cost of manufacturing semaglutide-based medications to meet the local standard. This will decrease the costs for international manufacturers that rely on Indian testing and production facilities while also promoting domestic manufacturing for companies that only sell their products abroad. Meanwhile, the new regulations might put smaller pharmaceutical companies at a disadvantage over larger competitors due to the increased costs and complexity of the production process.
