Latest news with #IndianPharmacopoeiaCommission
News18
7 days ago
- Business
- News18
‘Not A Regulatory Body': Indian Pharmacopoeia Clarifies It Only Sets Standards For Drugs, Doesn't Enforce Them
Last Updated: The clarification comes in the wake of increased global scrutiny of Indian-made drugs The Indian Pharmacopoeia Commission (IPC) has issued a clarification on its role amid growing concerns over impurities in medicines and the quality of drug manufacturing in India, News18 has learnt. In a notice issued by the apex authority titled 'Clarification on impurity limits published in the Indian Pharmacopoeia", it mentions that the IPC 'is in receipt of enquiries from various stakeholders…" and hence, it has been issuing the clarification. The IPC, which is responsible for setting the official quality standards for medicines in India, made it clear that while it defines the standards for impurities in drugs, it is not involved in approving or regulating new medicines. It said that responsibility lies with regulatory bodies like the CDSCO (Central Drugs Standard Control Organisation) and State Licensing Authorities. Both government departments, the Indian Pharmacopoeia Commission (IPC) and the apex regulatory agency, CDSCO, are headed by Dr Rajeev Singh Raghuvanshi. Impurities are small amounts of unwanted substances that may be present in a drug. While some impurities are acceptable within strict limits, their control is crucial to ensure the safety and effectiveness of medicines. The IPC sets impurity limits based on global standards and scientific data submitted by drug manufacturers. These limits are meant to serve as guidelines for making safe medicines, but final approval is always in the hands of the drug regulators. 'The IPC is an autonomous institution under the Ministry of Health & Family Welfare that is solely responsible for setting official drug standards… The IPC does not have any role in the regulatory review and approval of new drugs in India…the CDSCO and/or state licensing authorities are competent to take regulatory decisions." The clarification comes in the wake of increased global scrutiny of Indian-made drugs. Experts had raised questions about whether the IP includes adequate impurity limits for commonly used medicines. However, IPC, in the notice, has reiterated that it works in a consultative and advisory capacity, not as a regulator or certifying body. 'Impurities may be considered by the regulatory authority, provided it is supported with valid scientific justification and relevant data," it said. The notice, signed by Raghuvanshi, also pointed out that 'it is clarified that, in any case, the IPC does not have the mandate to approve or endorse impurity specifications…" Moreover, it added, 'the IPC, being a standard-setting organisation, is also not responsible to express opinion or recommendation in such regulatory matters." In fact, it has asked drug-makers and stakeholders 'to engage with the IPC by submitting scientific evidence to support monograph revisions, wherever required, to promote harmonisation with global standards". First Published: June 04, 2025, 10:26 IST
Mint
23-05-2025
- Health
- Mint
Govt alert: common antibiotic treatment may be ‘life threatening'
New Delhi: The Indian Pharmacopoeia Commission (IPC), a body under the health ministry, has found a commonly used antibiotic combination—sulfamethoxazole and trimethoprim—to have shown serious adverse reactions. This fixed dose combination drug is a popular antimicrobial medication used for the treatment of a wide range of bacterial infections such as pneumonia, bronchitis, skin infection, granuloma, urinary tract infection etc. The commission noted that the drug is showing serious adverse reaction in the form of leukopenia, a life-threatening condition which lowers the white blood cell count. 'The analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database revealed that suspected drug–Sulfamethoxazole + Trimethoprim–used for indication(s) like Urinary Tract infection; Respiratory-tract infection including Bronchitis, Pneumonia, infections in Cystic Fibrosis, Melioidosis, Listeriosis, Brucellosis, Granuloma Inguinale, Otitis Media, Skin infection, Pneumocystis Carinii Pneumonia— is showing adverse drug reaction called Leukopenia,' IPC in a drug alert for the month of May, seen by Mint. IPC asked healthcare professionals, patients and consumers to closely monitor for any adverse reaction with the drug and report to the authorities if such a reaction occurs. Medical experts said that doctors should be cautious when prescribing this combination, especially for vulnerable patients, and regular blood tests can help catch any issues early. 'Trimethoprim-sulfamethoxazole has been used for years to treat a range of common bacterial infections because it's effective and widely available. But the recent alert from the Indian Pharmacopoeia Commission about its link to leukopenia—a drop in white blood cells—is an important reminder that even well-known medicines can have serious side effects. A low white cell count can make it harder for the body to fight infections, especially in older adults or people with weaker immune systems,' said Dr R.R. Dutta, HOD, Internal Medicine, Paras Health Gurugram. The IPC monitors adverse drug reactions among the Indian population and recommends the Central Drugs Standard Control Organization (CDSCO) to take suitable regulatory decisions for safe use of medicines. Earlier, Mint reported that the Drugs Controller General of India has directed states/UTs to keep a close surveillance on the sale of unapproved antibiotic combinations and ensure that these cocktail drugs do not find their way to the market. The plan is to stop the misue of antibiotics. Last year, the IPC issued 10 drug safety alerts. Antimicrobial resistance (AMR), often due to overuse or wrong use of drugs, has emerged as a serious and growing threat to public health across the world, with around 600,000 lives being lost in India each year due to such AMR infections, as per the data available with the ministry of chemical and fertilizer. Queries sent to the health ministry spokesperson remained unanswered. According to Crisil market intelligence and analytics, the market size of the anti-infective segment in India stood at about ₹ 251.3 billion for FY24. These include antibiotics, antivirals, and antifungals.
