The Central Drugs Standard Control Organisation (CDSCO) has directed all state and Union territory drug controllers to ensure that medicines containing enclomiphene and its combinations are not manufactured, sold or distributed, according to two government officials and a communication reviewed by Mint.
Enclomiphene is a non-steroidal selective estrogen receptor modulator used to treat male infertility. However, enclomiphene and its combinations have not been approved for manufacture or marketing in India.
Under Indian laws, the manufacture, sale, and distribution of prohibited, banned, and unapproved drugs is a punishable offence under Section 18 of the Drugs and Cosmetics Act, 1940.
"It has been brought to the notice of this directorate that certain manufacturers are manufacturing and/or marketing drug products containing enclomiphene and its combinations without obtaining the requisite permission from the Central Licensing Authority, despite such products falling within the definition of a 'New Drug’ under the provisions of the New Drugs and Clinical Trials Rules, 2019,” said Raghuvanshi in the communication.
Verification drive
State and Union territory drug controllers must immediately trace manufacturers, marketers, distributors, and retailers dealing in unapproved enclomiphene products, initiate regulatory action, and ensure these items are not manufactured or sold within their jurisdictions.
They must also submit an action-taken report detailing the identified manufacturers, regulatory proceedings initiated, and the present compliance status to the central directorate. Copies of the circular have been sent to the CDSCO zonal and sub-zonal offices and pharmaceutical industry associations.
“Because the central authority currently lacks records on the entities producing or selling these unauthorized products, it has initiated a nationwide verification drive to identify them through state licensing authorities,” said one of the two government officials cited above on condition of anonymity.
The move could have ramifications for India’s male infertility drugs market, valued at around $102.8 million, according to business consulting firm Grand View Research. Mint could not ascertain the names of manufacturers making medicines containing enclomiphene and its combinations.
The DCGI is coming down heavily on unapproved drugs and is in discussions with state regulators to enforce compliance, a move impacting India’s $60 billion pharmaceutical market.
CDSCO crackdown
Mint earlier reported that the regulator is cracking down on unauthorized drugs by reconciling national registries and tracing legacy state licences issued before 1988, when central approval rules began. The exercise aims to remove unapproved formulations that entered the market without central safety evaluations.
“Under relevant provisions of the Drugs and Cosmetics Rules, 1945, and the New Drugs and Clinical Trials Rules, 2019, any new substance, modified indication, or added fixed-dose combination strictly falls under the definition of a 'new drug' requiring a DCGI approval,” said Uday Bhaskar, honorary director general at the All India Drugs Control Officers' Confederation (AIDCOC) and former director general of Pharmexcil, the agency responsible for promoting the export of Indian pharmaceutical and healthcare products.
The DCGI is legally justified in advising the SLAs (state licensing authorities) against unapproved formulations. The central law prevails, and long market presence or state licences cannot justify bypassing the CDSCO list of more than 5,000 approved drugs, he said.
If manufacturers claim efficacy without side effects, the onus is on them to submit clinical evidence rather than challenging the DCGI advisory, he added.
Mint's queries emailed to the spokespersons of the health and family welfare ministry and the DCGI office on 19 August remained unanswered.
Public health experts say that consuming unapproved drugs can lead to poor treatment outcomes.
“Medicines that have not undergone evaluation and approval by India's regulatory authorities may not meet the required standards of safety, quality, and efficacy,” said Aashish Chaudhry, managing director, Delhi-based Aakash Healthcare Super Speciality Hospital.
"One of the biggest dangers is that patients often remain unaware that they are consuming unregulated products. Such medicines may contain incorrect ingredients, improper dosages, contaminants, or may even be counterfeit.”