Regulation of medicine production and sale: President signs drug authority bill

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ISLAMABAD, Nov 12: President Asif Ali Zardari signed a bill on Monday for setting up the Drug Regulatory Authority of Pakistan (DRAP) to prevent sale of fake, substandard and non-registered medicines and regulate manufacturing, storage, distribution, import, sale and advertising of therapeutic drugs.

The bill called the Drug Regulatory Authority Bill-2012 was signed at a special ceremony at the Presidency.

According to objectives of the bill, the DRAP will advise the federal government on issues relating to obligations and commitments made with international organisations relating to therapeutic goods, including drugs, medicines and medical devices, besides developing ethical criteria on drug promotion, marketing, advertising and the rational use of drugs, including research and development.

Under the law, the authority shall undertake measures to ensure self-sufficiency in medicines and allied therapeutic goods to create conducive environment for manufacture, import and promotion of export.

According to clause 5 of the bill, the federal government may, on recommendations of the board, appoint a person as the chief executive holding a post-graduate degree in pharmacy or medicine with a minimum of 20 years’ experience in management or pharmaceutical field or regulatory affairs, in public sector.

Addressing the gathering after signing the bill, the president congratulated parliament and all political parties on the unanimous adoption of the bill and said it was a sign of wisdom and maturity of parliament and all political parties.

President’s spokesman Senator Farhatullah Babar quoted the president as saying: “Credit goes to government of Zulfikar Ali Bhutto to first promulgate the Drug Act, 1976, and it goes to this coalition government to establish for the first time the Drug Regulatory Authority in the country, like in advanced countries of the world.”

He said all provincial assemblies and governments deserved to be commended for agreeing to permit the federation to make this important legislation for the benefit of all. It was a measure of their political maturity.

“A noteworthy feature is that not a single employee of the devolved Drug Control Organisation of the health ministry had been laid off and their salary and pension benefits have been protected in the act,” he said.

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