India Pharma Outlook Team | Wednesday, 12 August 2026
Fertility drug regulation has come under scrutiny after the Central Drugs Standard Control Organization flagged the unauthorized manufacture.
CDSCO directed drug controllers across states and Union territories to identify companies involved in manufacturing, marketing, distributing or retailing these products.
The regulator also asked authorities to initiate action under the Drugs and Cosmetics Act, 1940, and submit action-taken reports.
The development puts regulatory compliance, product approval and enforcement at the center of India’s fertility drug market.
Studies have found that the drug can raise serum testosterone while maintaining sperm production, which has made it relevant to the treatment of male infertility and secondary hypogonadism. Against this backdrop, CDSCO has flagged the unauthorized manufacturing and marketing of Enclomiphene-containing products in India.
Enclomiphene is a selective estrogen receptor modulator (SERM) that stimulates the body’s own testosterone production by increasing the release of luteinizing hormone and follicle-stimulating hormone.
The regulatory issue centers on Enclomiphene’s status as a new drug under the New Drugs and Clinical Trials Rules, 2019. This classification requires companies to secure permission from the Central Licensing Authority before they manufacture or market products containing the drug. CDSCO has therefore asked state regulators to prevent unauthorized products from entering or remaining in the market.
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CDSCO has asked them to trace every manufacturer, marketer, distributor and retailer dealing with Enclomiphene products without the required approval. Regulators must also initiate appropriate action and ensure that companies do not manufacture, sell, distribute or market the unauthorized products within their jurisdictions.
Where applicable, authorities can suspend or cancel manufacturing permissions under the Drugs and Cosmetics Act, 1940. CDSCO has also asked states to submit action-taken reports detailing the companies identified, measures initiated and current compliance status.
The Enclomiphene action highlights the importance of central approval for products that qualify as new drugs. For pharmaceutical companies, the directive creates a clear compliance requirement around the development, manufacture, and commercialization of Enclomiphene-based products.
For the broader fertility drug market, the action also establishes a specific enforcement trail to identify unauthorized operators, stop unapproved manufacturing and sales, take action under existing law and report compliance to CDSCO. The regulator’s move therefore places product approval and enforcement at the center of the current Enclomiphene issue rather than treating it as a routine market-distribution matter.
