President ratifies bill on drug regulatory body

Published: November 13, 2012
President Asif Ali Zardari signing new bill into law during a special signing ceremony. PHOTO: APP

President Asif Ali Zardari signing new bill into law during a special signing ceremony. PHOTO: APP


President Asif Ali Zardari on Monday signed into law the much-anticipated Drug Regulatory Authority Bill 2012 (DRAP) that sanctions the creation of an autonomous drug regulatory authority and restricts the sale of counterfeit and substandard medicines in the country.

The regulatory body will ensure the availability of safe and quality medical services at affordable prices.

Addressing the signing ceremony, President Zardari congratulated parliament over the passage of the bill. The bill, according to the president, will ensure that the interests of both patients and pharmaceutical companies are protected.

The president expressed satisfaction over the pharmaceutical industry’s growth trajectory since 1947, swelling from just a few manufacturing units at the time to more than 600 well-developed units today.

Underscoring the need to broaden base for research and development, he said that biotechnology was the engine of growth of the present century.

“Our academia needs to work closely with the industry to ensure timely infusion of related knowledge,” the president said.

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

The president also called for expanding the scope of pharmaceutical exports and making new advancements in the area.

Commenting on the bill, presidential spokesperson Senator Farhatullah Babar said the DRA had been designed matching international standards.

Such bodies have been established in advanced countries with the aim of protecting the interests of patients, the pharmaceutical industry and officials working in the industry, he added.

The bill was moved by Minister for National Regulation and Services Dr Firdous Ashiq Awan, and was approved after much wrangling by both houses.

The establishment of Pakistan’s Drug Regulatory Authority would bring revolutionary changes in Pharmaceutical industry by regulating the manufacturing, distribution and sale of medicines in the country, Awan told The Express Tribune.

Salient features

According to the new law, stern action would be taken against companies involved in manufacturing of counterfeit medicines, ensuring that the rights of patients are protected.

Furthermore, a Drug Policy Board will also be formed, and will be headed by the national regulations and services secretary.

The DRA will be headed by a chief executive officer (CEO), who will be appointed on merit by the prime minister on recommendation of members of the Drug Policy Board.

The board will consist of 16 members, out of which six will be nominated by the provincial governments, while two will be picked from pharmaceutical industry.

It further states that the board will operate with autonomy and will not be interfered by political or bureaucratic influences.

Published in The Express Tribune, November 13th, 2012.

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Reader Comments (4)

  • Rafique Khan
    Nov 13, 2012 - 7:46AM

    It is useless efforts by the Government there is no any benefit to common people in Pakistan. After passing and ratification of this bill Government need to provide benefits to the Pharmaceutical Companies in Pakistan. During this PPP regime in the country the Ministry of Health is totally failure to catch the companies who are involved in the malpractices of counterfeit products.


  • Khan
    Nov 13, 2012 - 10:37AM

    Strange! there was no category in the awards for ethical practices. Is it because no medicine company in Pakistan can lay claim for award in that area? Medicine companies are sucking the blood of poor patients and sharing it with the doctors.Recommend

  • Nov 13, 2012 - 11:40AM

    After sixty-five years they wake up now. Affordable prices, quality, and spurious drugs cannot be controlled especially, when you have no law enforcement and weak courts compounded by corruption and illiteracy.
    A daily recurring feature is shortages and arbitrary increases in the prices of medicines (Actifed P is not available since the last four months). No point in elaborating it further because its a well known feature in everyday life. Most of the valuable medicines are being exported because of the exchange rate favoring the exporters.
    The CEO of the DRA will be appointed on merit by the PM who is a dual national. Haaahh! Why don’t they say a person acceptable to both sides of the political divide. Salams


  • H.Dr.Hafeezullah, M.Phil.(Phytomedicine)
    Nov 17, 2012 - 5:26PM

    An high profile post graduate homeopathic doctor may also be included in Drug Regulatory Authority to control the homeopathic drugs as same are being made locally and even diploma holder homeopathic doctors use to soak tablets and globules with homeopathic dilutions which are spoiled if stored many times out of alcohol. That is why efficacy of homeopathic medicines are lost and a diploma holder homeopath is Un aware of these pharmaceutical changes.Its very much necessary to warn homeopathic pharmaceutical companies and homeopaths to prescribe and dispense only labelled and well reputed company packed medicines.They must strict monitor not to dispense un labelled and / or loose medicines.


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