Registration of Tadalafil for sexual health disorders in Pakistan

Islamabad : The Drug Regulatory Authority of Pakistan (DRAP) has officially granted registration of Tadalafil, a key medication used in the treatment of sexual health disorders, to 4 Pakistani pharmaceutical companies. This is a highly welcome and historic step that will not only ensure the availability of quality medicine to patients but also help eliminate counterfeit, smuggled, and illegally marketed drugs.

Highnoon Pharmaceuticals, Lahore, has also received registration for this medication and has formally launched it in the Pakistani market . Until now, only Sildenafil Citrate (Viagra and other brands), which was already registered with DRAP, was available in Pakistan.

In the past, such sexual health medications were widely available across Pakistan through smuggling, illegal sales, and substandard products — posing a serious threat to public health. Now that Tadalafil will be available through DRAP-approved companies, it is nothing short of a blessing for the people of Pakistan.

The medication is especially beneficial for patients suffering from diabetes, heart disease, and erectile dysfunction, offering a safe and effective treatment option.

Noor Mahar, Advocate and President of the Pakistan Drug Lawyer Forum (PDLF), termed this development as a major success of DRAP and expressed hope that similar decisive actions will be taken for the registration and availability of other essential medicines.

Registration and Launch of Tadalafil – A Significant Milestone
Noor Mahar, President, Pakistan Drug Lawyer Forum
The Drug Regulatory Authority of Pakistan (DRAP) has officially registered Tadalafil — a well-known medication used in the treatment of sexual disorders — for four Pakistani pharmaceutical manufacturers. This crucial decision is being seen as a positive move for public health in Pakistan.

Highnoon Pharmaceuticals, Lahore, has taken the lead in this regard and officially launched its brand “Fildil” today — a high-quality Tadalafil formulation. The medicine will now be legally, safely, and readily available across the country.

Sexual Health Medicines Market in Pakistan – Background

Pakistan has a large market for sexual health medications. Until a few years ago, nearly 33 counterfeit and unregistered brands were widely available in the market, most of which were smuggled or illegally imported from India. This trend was particularly rampant in Khyber Pakhtunkhwa (KPK), Balochistan, and Sindh.

At that time, even syrup formulations and other illegal brands of Sildenafil Citrate (Viagra) were being sold unlawfully. Now that DRAP-registered brands, especially Highnoon’s “Fildil”, are available, this marks a historic success in the country’s regulatory and healthcare system.

Response from the Medical Community

Pakistan’s medical professionals, urologists, and doctors have welcomed this development, considering it a step toward safe and effective treatment for patients — especially those suffering from diabetes, cardiovascular diseases, and sexual dysfunction.

Pharmaceutical Community’s Appreciation

The pharmacist and pharmaceutical community of Pakistan has also praised this decision, welcoming Highnoon Pharmaceuticals and other DRAP-registered companies. A special tribute has been paid to the leadership of DRAP, particularly the Chief Executive Officer (CEO-DRAP), for taking this commendable action.

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