Tapentadol Hydrochloride

New Delhi: Small pharmaceutical firms in India have raised strong objections to new guidelines issued by the Central Drugs Standard Control Organisation (CDSCO) regarding the issuance of No Objection Certificates (NOC) for exporting both approved and unapproved new drugs. In a letter to Union Minister of Chemicals and Fertilizers JP Nadda, the RSS-affiliated Laghu Udyog Bharati (LUB)—a body representing small-scale industries—stated that it would be difficult for MSME units to comply with the new export NOC procedures. The letter reads: “Due to the wrongdoings of a few companies, genuine pharma exporters should not be penalized. It will be difficult for an MSME unit to meet the conditions of the new export NOC procedure.” “Due to this NOC hurdle, neighboring countries will capture the export market, and that will be a permanent dent to Indian pharma exports. We have a few suggestions to ease this process without compromising ‘Brand Bharat’,” it added. On March 7, 2025, CDSCO issued a “guidance document for issuance of no objection certificate for manufacture of unapproved/approved new drugs for export purpose.” Notably, LUB raised concerns about the initial version of the document. Earlier this month, CDSCO released a revised version with several amendments. A major concern cited by industry stakeholders is the requirement for approval from the National Regulatory Authority (NRA) of the importing country. According to the guidance, manufacturers must obtain such approval. If a product (either API or formulation) is already registered and approved by the NRA for a specific firm, that approval may be considered applicable to other applicants. The revision to the export process was made in the wake of a BBC report that linked a Mumbai-based drug manufacturer, Aveo Pharma, to the West African opioid crisis. As per the report the company allegedly manufactured and illegally exported two unapproved drugs—Tapentadol and Carisoprodol—implicated in a public health crisis involving opioid addiction in Nigeria and Ghana. Meanwhile, in its letter, LUB also reiterated its longstanding demand for the establishment of a Drug Tribunal Board to oversee prosecution matters involving various state authorities and CDSCO. The organisation noted that the previous minister had instructed the Secretary of the Department of Pharmaceuticals to create a roadmap for such a tribunal, similar to those established under FSSAI, GST, and Income Tax laws, which help resolve issues more efficiently and leave only serious offences to be addressed in judicial courts. LUB also urged that no risk-based inspections be conducted until the notified deadline of December 31, 2025, for implementing revised Schedule M requirements. Furthermore, it requested that manufacturers with an annual turnover below ₹50 crore be granted a one-year extension to comply with Schedule M norms—pushing their deadline to December 31, 2026. Under the Drugs and Cosmetics Rules, 1945, Schedule M outlines Good Manufacturing Practices (GMP) that all pharmaceutical manufacturers in India must follow. These regulations cover facility premises, equipment, plant operations, and quality assurance processes to ensure that drugs are consistently produced to meet specified quality standards. In December 2023, the Ministry of Health and Family Welfare had notified revised Schedule M requirements. Small manufacturers with a turnover of less than ₹250 crore were granted a compliance extension until December 31, 2025. By Online Bureau ,

New Delhi: Exactly two months after issuing guidelines for obtaining NOC to export approved and unapproved drugs, the Central Drugs Standard Control Organization (CDSCO) has issued a revised document dropping the earlier notified requirement of unique registration in the importing country. The initial guidance document issued by the apex regulatory body on March 7 had mandated that firms seeking export NOC had to submit approval status of the applied Drug (s) as issued by the National Regulatory Authority (NRA) of the Importing country. Whereas the revised document issued by the body states that if the product is registered and approved by the NRA for a specific firm, such approval may be considered applicable for other applicants. “The firm needs to submit approval status of the applied Drug (s) as issued by the NRA of Importing country. In case NRA approval is not applicable, then approval status of India may be submitted,” the initial document reads. However the revised version suggests that, “in case the pharmaceutical product (API or formulation) has been registered and approved by the National Regulatory Authority (NRA) of the destination country for a specific firm, such approval may be considered applicable for other applicants.” Notably, the revision has been made following the objections raised by the government backed export promotion body Pharmexcil. As per a media report in a letter addressed to the Drugs Controller General of India (DCGI), the industry body was concerned that the amendment will “significantly strain India's pharmaceutical export sector and sought a review of the then new rule. The revision was made following a controversy based on a BBC report which suggested the alleged involvement of a Mumbai-based drug maker Aveo Pharma in the West African opioid crisis. The company was charged with manufacturing and illegally exporting two unapproved drugs—Tapentadol and Carisoprodol—which have been linked to a serious public health crisis of opioid addiction in countries such as Nigeria and Ghana While issuing the guidance in March the body in it notice issued from the office of the DCGI had noted that to ensure “ease of doing business” CDSCO has streamlined the process of issuing export NOC for unapproved / approved new drugs through Sugam portal and To reduce the compliance burden, CDSCO has initiated the issue of a 1-year NOC, subject to prescribed conditions for such Drugs, it added. Under the new provisions manufacturers are required to fill an online Integrated Registration Form (IRF) one time before the grant of Export NOC which is valid for 1 year. Earlier, exporters had to obtain a separate, consignment-specific NOC for each export order whereas under the new rules companies can obtain a blanket NOC valid for one year, provided the drug is approved in the importing country and the company has a history of exporting that drug over the past year. Besides this the body has also overhauled the approval process, replacing the state-level clearances to a fully digital system administered through its SUGAM portal. As per the notified draft companies have to register themselves with zonal by filling the one-time Integrated Registration Form (IRF). The IRF will be verified by the concerned zonal office & NOC may be issued with 1year validity for the applied products within 7 working days from the date of Application, the guidelines suggest. By Online Bureau ,