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AIOCD mandates immediate recall of unapproved enclomiphene stocks following CDSCO’s order
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Peethaambaran Kunnathoor, Chennai
August 17 , 2026
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In a major move to safeguard the pharmaceutical supply chain, the All India Organisation of Chemists and Druggists (AIOCD) has issued an urgent compliance circular (Ref: APH/AIOCD/511/2026) instructing pharmaceutical manufacturers, distributors, and stockists to halt the distribution of unapproved enclomiphene formulations and immediately recall non-compliant stocks from the retail market.
The national trade body, representing over one million pharmaceutical trade members across India, swung into action following a strict enforcement directive from the Central Drugs Standard Control Organization (CDSCO). Signed by AIOCD president J S Shinde and general secretary Rajiv Singhal, the circular directs all pharma marketing and distribution heads to furnish valid Central Licensing Authority (CLA) permissions and manufacturing endorsements for any enclomiphene-based products currently circulating in the market.
Under the new directive, drug makers who lack proper CDSCO clearances must immediately stop commercial supply, notify trade partners across all distribution tiers, and initiate full product recalls from stockists and retail counters. The AIOCD warned that if manufacturers fail to provide authentic regulatory clearance within the given timeframe, the formulations will be classified as unapproved, and retailers will return all existing stock to the respective companies for full credit.
The trade association’s intervention stems from a central regulatory order signed by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi. The CDSCO identified that several manufacturers were producing and marketing enclomiphene, a selective estrogen receptor modulator (SERM) used in reproductive medicine, without obtaining mandatory prior clearance. Under Rules 2(1)(w), 19, and 80 of the New Drugs and Clinical Trials Rules, 2019, enclomiphene and its combinations are categorized as 'New Drugs,' requiring formal clearance in Form CT-21 before commercial production or trade.
Highlighting the legal precedent, the central regulator clarified that state licensing authorities do not hold the legal mandate to grant product permissions for 'New Drugs' without central endorsement. Because enclomiphene and its active combinations currently lack CLA approval for manufacture or sale in India, any ongoing trade remains illegal under the Drugs and Cosmetics Act, 1940, subjecting non-compliant entities to potential license suspensions and penal action.
By acting swiftly on the regulator’s directive, the AIOCD leadership reinforced its commitment to patient safety, clinical efficacy, and supply chain integrity. The trade body urged pharma executives to maintain strict statutory compliance, ensuring retail chemists are protected from legal liabilities while maintaining consumer confidence in prescription medicines.
As state drug regulators prepare to submit Action Taken Reports (ATRs) to the CDSCO, the AIOCD’s decisive intervention is expected to force pharmaceutical companies into immediate market recalls or prompt them to seek formal central approval for their enclomiphene formulations.
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