President Asif Ali Zardari.—Reuters Photo

ISLAMABAD: Pakistan’s President Asif Ali Zardari on Monday signed the Drug Regulatory Authority Bill 2012, bringing into law the establishment of a regulatory body to oversee the manufacture and trade of medicines.

The legislation was required after the heath sector was devolved to the provinces under the 18th Amendment. The provincial governments had authorised the federal government through resolutions to set up the authority for inter-provincial trade and commerce of drugs and therapeutic goods to regulate, manufacture, import and export, storage, distribution and sale of therapeutic goods and medical devices and drugs research.

According to the bill, a 16-member policy board will be formed by members of pharmaceutical companies. The prime minister will appoint the chief executive officer (CEO) to head the regulatory body from the recommendations forwarded by the policy board.

The Senate and National Assembly had earlier approved the bill in October, despite disagreements around a typographical error in the draft bill.

Addressing the signing ceremony here at the Presidency on Monday, President Zardari said that the act would ensure availability of safe and quality medical services at affordable prices to the people.

He said that the law would help prevent the sale of fake, sub-standard and non-registered medicines and stop hoarding by creating an autonomous drug regulatory authority.

The President stressed the need to broaden base for research and development and said that bio-technology was the engine of growth of the present century.

“Our pharma industry needs to harness this technology and the academia needs to work closely with the industry to ensure timely infusion of related knowledge.”

He stressed on the industry to focus on acquiring international standards of quality control and called for adopting corporate culture within the regulatory system.

Later briefing the media representatives, the President’s spokesperson Senator Farhatullah Babar said that a conscious and deliberate effort was made during the past several months to involve all the stakeholders in the finalization of the bill.

He said that the Pharmaceutical Association, the Pharma Bureau and the Pakistan Chemists and Druggists Association in addition to the standing committees of the National Assembly and Senate were included in the broad-based consultation and dialogue process to arrive at a consensus.