Why India is making 120 medicines, including those for type 2 diabetes and obesity, more accessible

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International tender for procurement of 120 medicines could ease access to some patented medicines in India. Commentary.

The government has allowed Indian medical institutions to invite international tenders for 120 patented or proprietary medicines that are not currently sold in the country. This includes semaglutide, used to treat type 2 diabetes and obesity. Here is an explanation to help you understand the process. What is the standard practice? In India, for tenders below Rs 2 billion, only Class 1 and Class 2 Indian manufacturers can participate in the tenders.

The government has allowed Indian healthcare institutions to invite international tenders for 120 patented or proprietary medicines that are not currently sold in the country. This includes semaglutide, a drug for treating type 2 diabetes and obesity. Below is an explanation to understand the process. What is the standard practice? In India, tenders below Rs 20 crore can only be participated by Class 1 and Class 2 “Make-in-India” manufacturers. This is the normal provision. The government’s public procurement policy, as part of a strategy to strengthen the domestic industry, prohibits international tenders for procurement of goods and services up to Rs 20 crore. This means that healthcare institutions cannot freely procure certain medicines. This creates a bottleneck. This new notified drug list aims to remove this issue. Global Tender Enquiry (GTE) has now allowed healthcare institutions to invite tenders for these medicines. What happens next? Cancer medicines and medicines for rare diseases often have to be imported. In such situations, the notified list allows hospitals/healthcare institutions to invite international tenders. This means that anyone can participate. In case of patented or proprietary medicines, the original manufacturer, whose parent company is outside India, can directly participate. What prompted the change? This was done on the basis of requests from premier institutes like AIIMS and medical institutes like ESI and Army Hospital. A committee was constituted under the Director General of Drugs and after listening to all stakeholders, it made recommendations to the government. These recommendations were accepted by the government. The committee narrowed down the list to 120 medicines. Will these medicines be available in the open market? Once these large institutes start procuring them, they will also be available in the open market. It will be a big relief for patients as these medicines are specialised patented and proprietary medicines for various types of cancer and rare diseases and are not freely available in the open market. Will it be L1 (lowest bid) only? What points should be kept in mind to attract the interest of global giants while protecting the taxpayers as these institutes will be using government funds? Since this is an open tender, the bidding medical institutes will have to get the best price possible. They will also have to follow pre-qualification and technical standards before the companies apply for the tender. The institutes will follow these policies. For example, All India Institute of Medical Sciences and Army Hospital will also adopt their own procurement policies so there is no need to worry. Will it be manufactured in India? Not necessarily. However, once the drug finally starts manufacturing in India, it will have a sufficient market position. Indian manufacturers can also participate in bidding, but a drug may remain exclusive for some time even after the patent expires. This is because it takes time for companies to get the necessary approvals. When will the list of drugs be updated? It is a continuous process. The list is dynamic. Every year in January, there is a one-month period for claims and counterclaims. If an Indian manufacturer starts manufacturing generic drugs and gets the necessary approvals from the drug regulator of India, the imported drug may be withdrawn and the new drug may be added to the list.