The Federal Government has issued a notification through the Ministry of National Health Services Regulations and Coordination, granting pharmaceutical companies the authority to set prices for medicines not included in the National List of Essential Medicines (NEML).
The notification, released on Monday, highlights the government’s decision to exempt all drugs and biologicals not listed in the NEML from the constraints of Section 12 of the Drugs Act, 1976.
According to the notification, this exemption is exercised under Section 36 of the Drugs Act, 1976, and is deemed necessary in the public interest. Section 12 of the Drugs Act 1976 typically empowers the government to determine the maximum selling price of specified drugs and allocate a certain percentage of manufacturers’ profits for research purposes.
The recent move aligns with the rules governing research in drugs. Essential medicines, as defined by the Drug Regulatory Authority of Pakistan (DRAP), are those that address the primary healthcare needs of the population. They are intended to be consistently available in sufficient quantities, in appropriate dosage forms, with guaranteed quality, and at prices affordable to both individuals and communities.
Essential medicines, as per the World Health Organization’s model list, can be accessed on the DRAP’s website. This regulatory adjustment allows pharmaceutical companies greater flexibility in pricing for drugs that fall outside the scope of essential medicines, marking a significant development in the pharmaceutical sector in Pakistan.
