Indian Council of Medical Research

By Pratibha Raju and Vishal Kumar Singh Mumbai: Investigator-Initiated Clinical Trials (IICTs) represent a crucial category of academic research that focuses on exploring new therapeutic uses, dosing regimens, and patient populations for drugs already approved by regulatory authorities. Unlike industry-sponsored trials, which are primarily designed for regulatory approval or marketing purposes, IICTs are undertaken by academic investigators to generate scientific evidence that informs clinical guidelines and enhances patient care, said Dr. Jarin Jose Cherian, Senior Scientist, Indian Council of Medical Research ( ICMR ). Speaking at the second edition of the ETPharma Clinical Research and Excellence Conference (CREC) 2025 on the topic “Challenges in Investigator-Initiated Clinical Trials,” Dr. Cherian highlighted how, despite their importance in addressing unmet medical needs and expanding the evidence base, IICTs in India face significant challenges. These include limited funding, the absence of structured scientific review processes, and gaps in monitoring and oversight. He spotlighted the often-overlooked role of IICTs and urged the need for stronger frameworks to improve their quality, safety, and operational efficiency. While these trials typically involve approved drugs and are not meant for commercial gain, Dr. Cherian stressed that they are vital for generating real-world evidence. Such trials frequently investigate new indications, alternative dosing strategies, or distinct patient demographics and often evaluate endpoints that are especially relevant to public health, including mortality rates. “IICTs are not unregulated; they are governed by institutional ethics committees,” Dr. Cherian stated. “But without central oversight, many challenges persist—from protocol design to adverse event reporting.” Citing a recent ICMR study published in the Indian Journal of Medical Research (IJMR), he highlighted several key concerns, particularly the lack of a dedicated scientific review mechanism. While ethics committees do review proposals, they may not be equipped to thoroughly assess the methodological rigour of trial designs. In contrast to regulatory trials, IICTs frequently operate without the oversight of Data Safety Monitoring Boards (DSMBs), complicating efforts to maintain safety and consistency. “Poorly designed studies are not just unscientific—they’re unsafe,” he said. The absence of formal monitoring frameworks, the variable capacity of ethics committees, and the limited availability of statistical support or data management infrastructure all serve to weaken the reliability and safety of such trials. Dr. Cherian also emphasised the broader public health and economic value of IICTs. Drawing on the example of the Australian Clinical Trials Alliance, he pointed out that 25 IICTs conducted over two decades resulted in an estimated $2 billion in savings—70 percent of which came from improved health outcomes, with the remainder stemming from the avoidance of ineffective treatments. Despite their potential, India continues to lag behind in IICT activity, currently ranking 18th globally. The majority of trials registered with the Clinical Trials Registry–India (CTRI) remain industry-sponsored. Funding is a major barrier. However, as Dr. Cherian noted, such challenges are not unique to India; even globally, IICTs face similar issues relating to infrastructure, governance, and support. To address these persistent gaps, Dr. Cherian advocated for comprehensive systemic reforms. These include strengthening the accreditation and capacity of ethics committees, mandating scientific review through institutional review boards, and establishing dedicated monitoring units—particularly for publicly funded or high-risk trials. He also recommended encouraging the use of DSMBs or independent safety evaluation committees and formalising adverse event reporting systems beyond voluntary mechanisms such as the Pharmacovigilance Programme of India (PvPI). Another area requiring attention is the development of innovative funding models to cover costs such as indemnification and insurance, especially in higher-risk trials. Outlining a comprehensive cycle of evidence generation—beginning with the collection of real-world data, followed by hypothesis testing in IICTs, and culminating in the development of clinical guidelines—Dr. Cherian said, “If integrated well, IICTs can meaningfully complement regulatory trials and inform more nuanced clinical decisions.” He concluded by emphasising that IICTs must no longer be seen as peripheral, but rather as essential pillars of India’s research and public health ecosystem—provided they are supported by robust regulatory, financial, and operational frameworks. By Prathiba Raju ,

New Delhi: Despite concerns over presence of cancer causing agents in popular antacid Ranitidine and a recent recommendation by an expert panel for suspension of the drug, India's top drug advisory body has decided to ignore and form another "larger committee" to look into all aspects of the drug. It is widely sold in India under brand names like Aciloc, Rantac and Zinetac. After a meeting held last week, the Drugs Technical Advisory Body (DTAB) also recommended that the Indian Council of Medical Research (ICMR) should conduct a study to assess the safety of the drug. The drug was withdrawn/suspended by regulatory bodies including the USFDA, European Medicines Agency (EMA), and Australia among others, Last year a committee was constituted to examine the safety issue of Ranitidine in the light of the nitrosodimethylamine (NDMA) impurity. The experts got samples of Ranitidine tested at a government run laboratory. Of the 42 Ranitidine samples tested at the Central Drug Laboratory in Kolkata, 21 were found to contain NDMA impurities exceeding 0.32 PPM. This level surpasses the globally acceptable limit for the impurity, which is linked to an increased risk of cancer over a lifetime. After evaluating the global regulatory status of the drug and having found some of the samples in India exceeding the safety limit, the expert committee recommended for the "suspension of the drug Ranitidine for manufacture, sale and distribution in the country," it said. The committee also recommended that the people taking Ranitidine should consult their health care professional for other treatment options. By Teena Thacker ,

New Delhi: India's premier health research body has recommended a ban on popular painkiller and anti-fever medicine Nimesulide in patients below 18 years and those who are 60 and above, citing safety concerns. The Indian Council of Medical Research (ICMR) has recommended that all formulations of Nimesulide above 100 mg should be banned. The recommendations have been sent to the country's apex drug advisory body, which will decide on the fate of the drug in a meeting to be held this week. The decision to ban, if taken, will jolt leading pharma companies. In India, Nimesulide is available under brand names such as Nimulid, Nimtex, Nicip, among others. Dr Reddy's brand Nise is the largest selling Nimesulide drug in India. The market for Nimesulide stood at '497 crore, growing at 11% over the last 12 months, as per data from market research firm PharmaTrac. The controversial anti-inflammatory drug has been a cause of concern for long for health experts. In 2011, the union ministry of health and family welfare had banned the paediatric use of Nimesulide in children below 12 years of age and in January 2025, the government prohibited the production, sale and distribution of all Nimesulide formulations for veterinary use. Earlier, ICMR was tasked by the health ministry to study the impact of Nimesulide on adults amid concerns that the drug could cause liver damage in some patients, which might prove fatal. Now, in a set of recommendations to the Drugs Technical Advisory Board (DTAB), ICMR has recommended a total ban on all formulations of Nimesulide above 100 mg. The experts also agreed that there is significant risk when Nimesulide is administered to patients below 18 years of age and elderly (60 and above). They found that the elderly have an increased frequency of adverse reactions with the use of Nimesulide, especially gastrointestinal bleeding and perforation, which may be fatal. "All experts agreed that nimesulide is contraindicated in elderly population (60 and above)," said a person in the know. The ICMR also found that Nimesulide may impair female fertility and is not recommended in women attempting to conceive. Keeping in view the safety concerns, the experts have recommended that the manufacturers place a black box warning on Nimesulide labels for all medicines that contain Nimesulide whether single agent or combination about the serious or life threatening risks associated with the drug's use. "The evidence supporting the ban of Nimesulide in the adult population is compelling," the ICMR has said in its report, adding that the drug's association with severe liver injury and other adverse effects presents an "unacceptable risk", especially given the availability of safer alternatives. By Teena Thacker ,