By Sheetal Sapale
The Central Drugs Standard Control Organisation has waived local trials for certain drugs approved in select markets. Sheetal Sapale explains how this will make drugs manufactured outside India more accessible & affordable
How has the approval process for new drugs changed?
AS PER THE Drugs and Cosmetics Rules, the safety and efficacy of any drug to be used by humans are required to be demonstrated before they can be approved for import or manufacturing and marketing in the country. There are specific guidelines to conduct clinical trials for different category of products. The Drugs Controller General of India gives approval to conduct clinical trials of new drugs, including Investigational New Drugs (IND). For new drug substances discovered in India, the clinical trials need to be conducted in India from the first phase itself. For those discovered outside of India, the data of the first phase is required along with the application.
The skipping of clinical trials after this order may shorten the process as far as evaluating the efficacy and safety of the product is concerned for the Indian population. However, FDA (Food and Drug Administration) review and approval may be compromised.
Why was there a need for this waiver?
RULE 101 OF the New Drugs and Clinical Trials Rules, 2019 allows the DCGI to specify certain countries for considering waiver of local clinical trials. It means that the innovative treatments developed in the European Union, the US, the UK, Australia, Canada and Japan can now be made available to patients in India in a shorter time span. The waiver applies to five categories of drugs, including those for rare diseases, gene and cell therapies, pandemic-related drugs, defense-related drugs, and drugs with significant therapeutic improvements over current treatments. The waiver would result in faster launches of innovative medicines in the country. The eligible patients who can afford the cost of innovative therapy can get the benefit for the same. Also, the move will prevent the unauthorised entry of products launched abroad but still not available in India.
Implications for pharma companies & contract research organisations
THE MULTINATIONAL PHARMA companies can launch their cutting-edge products in the country faster. They can capture the market opportunities without having to wait for the clinical trial approvals which take a couple of years. On the other hand, the waiver could affect the domestic pharma firms and contract research organisations (CROs). For instance, new international firms can enter the Indian market more easily, which can heighten the competition. The launch of a new product in a new geography requires significant research and regulatory-compliant data. The pharmaceutical companies assign this task to CROs who have technical expertise in this area.
If the need to do clinical research reduces, the local CROs would be adversely impacted as they will find it difficult to get new business from the pharmaceutical and biotech firms.
Circumstances where trials will be mandatory
THESE WAIVERS APPLY to some specific countries. So for the rest of the world, the companies will still have to follow the clinical trials guidelines to launch a product in India. The clinical trials carried out in the country of origin have a population base of different genetic structure, food and lifestyle habits and exposure to different environmental conditions. The drugs that would have impact on efficacy and safety based on any of the above conditions would still need clinical trials in India.
Also, a key point to note is that India is a diverse country. Within India, there are various regions, and this waiver disregards the need to assess the performance of new drugs across different genetic and ethnic groups.
Will the waiver compromise the safety of patients?
COMPANIES CARRY OUT all the clinical trials that are mandatory by the Indian governing bodies before the launch of any product. This also ensures that their licence to manufacture and market any drug stays safe and secure. In the current scenario, the waiver can reduce the barriers for companies who might launch experimental products in the country. The government has to ensure that the “relaxed regulations” don’t result in “untested” drugs being launched in India, especially the ones which are not sold in the countries of their origin due to concerns around patient safety. Also, the government’s job is to nudge companies to conduct trials on patients post the launch in India.
(The writer is vice president (commercial) at Pharmarack Technologies. Views expressed are personal.)