NEW DELHI: The Centre is preparing to crack down on the illegal sale, distribution and misuse of sexual enhancement medicines, with the drug regulator warning that it has become a threat to both public safety and social dignity, according to two government officials and a document reviewed by Mint.
This regulatory action against unauthorized products sold without valid prescriptions has been ordered by Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi. Apart from the physical risks, the Central Drugs Standard Control Organization (CDSCO), the regulator, has expressed alarm over serious social concerns arising from the misuse of these drugs, particularly their unregulated sale to younger people.
The use of sexual performance medicines such as sildenafil, tadalafil and vardenafil for erectile dysfunction and dapoxetine for premature ejaculation without medical advice can be risky, experts said. They can affect the flow of blood and may interact with other drugs. Side-effects can include a dangerous drop in blood pressure. Counterfeit or unregulated medicines may contain unsafe ingredients or wrong doses.
To combat the vexed issue, the CDSCO has outlined a four-point mandate for all state and Union Territory drug controllers: raids against illegal clinics, unauthorized pharmacies and unregulated online platforms; new legislative measures; educating law enforcement agencies including the police on the risks posed by these substances; and stricter monitoring to strengthen compliance with prescription norms and licensing conditions.
Sun Pharmaceutical Industries, Cipla, Mankind, Zydus Lifesciences, Eli Lilly & Company, Alkem Laboratories and Dr Reddy’s Laboratories are among the leading manufacturers of sexual enhancement drugs in India’s $1.15 billion sexual wellness market.
The regulatory action follows a representation made by BJP Rajya Sabha Member of Parliament Dr. Ajeet Madhavrao Gopchade, who said there is widespread misuse of sex-enhancing drugs, often driven by performance anxiety and a desire to increase confidence.
Significant risk
“A major section of people takes these medicines without any clinical necessity. There is a significant risk to public health from the black market as a significant number of medicines being sold in some areas are fake,” Gopchade, who is also a member of the Parliamentary Standing Committee on Health and Family Welfare and the governing council of the Indian Council of Medical Research, told Mint. “For products bought online, only a small percentage are genuine, while the majority are counterfeit.”
According to him, the main driver for this misuse is the social stigma around erectile dysfunction and the ease of buying cheap, unregulated boosters online. Health experts said consumption of these drugs can cause adverse effects.
“This is a timely and much-needed regulatory intervention, which aims to curb the malpractice of unethical advertising and unauthorized sale of medicines purporting to increase sexual potency,” said Dr K. Srinath Reddy, former president of the Public Health Foundation of India. “The use of such drugs, outside the ambit of medically guided prescribing, can lead to adverse effects on physical and mental health.”
The pharmaceutical industry appears to be aligned with the government’s move.
Arushi Jain, director at Akums Drugs & Pharmaceuticals Ltd, a contract drug manufacturer, said, “Stronger regulatory oversight can help bring more discipline into the system by ensuring that such medicines are prescribed and dispensed responsibly. Measures like coordinated enforcement and tighter monitoring of distribution channels are likely to improve accountability across the ecosystem.”
The drug regulator’s mandate emphasizes that these actions are in public interest and require immediate adherence from state-level regulators. By targeting the supply chain from online black markets to physical stores, the government plans to restore medical oversight to a sector currently dominated by illicit trade, the officials said.
Robust compliance
Online pharmacies emphasized that they comply with the highest standards of patient safety and trust and sell drugs only to patients with valid prescriptions.
“We fully support the CDSCO’s directive to strengthen oversight on the sale of prescription medicines, including sexual enhancement drugs,” said Rajeev Sharma, vice president of medical affairs at Tata 1mg. “All prescription medicines are dispensed through licensed pharmacies, with pharmacist supervision and robust compliance protocols.”
He added that whether the platform is online or offline, only patients who truly need these medications should receive them.
“Sexual enhancement medicines are identified and flagged at the backend. All such orders are processed only against a valid prescription,” said Madhivanan Balakrishnan, chief executive officer of Apollo 24/7. “Once a prescription is issued, medicines are dispensed only through licensed Apollo Pharmacy stores.”
Queries emailed to the spokespersons of the health and family welfare ministry, the DCGI office, Sun Pharma, Mankind, Dr Reddy’s Laboratories, Alkem Laboratories, Zydus Lifesciences, Eli Lilly and Cipla on 6 May remained unanswered till press time.