President Asif Ali Zardari on Monday signed Drug Regulatory Authority Bill 2012 into a law to prevent the sale of fake, substandard and non-registered medicines and to stop hoarding by creating an autonomous DRA, holding the key to regulate the manufacture, storage, distribution, import and sale and advertisement of therapeutic drugs.
The law aims at ensuring the availability of safe and quality medical services at affordable prices to the people and would protect the interests of the people as well as of Pharma industry in the country. The Bill was signed during a special ceremony held at Aiwan-e-Sadr on Monday, which was attended among others by Minister for National Regulations and Services Dr Firdous Ashiq Awan, member of the federal cabinet, parliamentarians, representatives of the pharmaceutical companies and others.
Addressing the gathering after signing of the Bill, the President congratulated the Parliament and all political parties, saying that unanimous adoption of the DRA Bill was a sign of wisdom and maturity of the Parliament and all political parties.
Spokesperson to the President Senator Farhatullah Babar said the President expressed satisfaction that the conscious and the deliberate effort mounted during the past several months and involving all stakeholders had successfully culminated in the finalisation of the DRA Bill. "Perhaps for the first time all Provincial Assemblies passed resolutions urging the federal parliament to enact legislation on an issue that concerned all provinces and for which the provinces thought that they had not yet developed mechanisms to address the issues."
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. For the first time in the history of Pakistan an autonomous DRA had been established holding the key to regulate the manufacture, storage, distribution, import and sale and advertisement of therapeutic drugs, Senator Farhatullah Babar said.
The President said the credit goes to the Government of Shaheed Zulfiqar Ali Bhutto for promulgating first the Drug Act, 1976 and to this coalition government for establishing for the first time the DRA in the country like in advanced countries of the world.
"The DRA has been designed along the lines such bodies have been established in advanced countries like the USA and Canada with the aim at protecting the interests of the patients, the Pharma industry and officials working in the Authority. A noteworthy feature is that not a single employee of the devolved Drug Control Organisation of the Health Ministry had been lid off whose salaries and pensioner benefits have been protected in the Act."
The President, in his speech, observed that the Pharma industry of the country had indeed grown over the past decades. From just a few manufacturing units at the time of independence, there were over 600 well-developed units today, the President noted. He said "today we have planted the seed of progress. Now it is the duty of all the stakeholders to nourish DRAP, own it and make it truly an effective regulatory authority."
The President said that after promulgation of DRAP law, it was time to take the next step in the technology. "We need to broaden our base for research and development," the President continued. He said biotechnology was the engine of growth of the present century. "Our Pharma industry needs to harness this technology. Our academia needs to work closely with the industry to ensure timely infusion of related knowledge," the President said.
He stressed that Pharma industry should now focus on acquiring international standards of quality control, adding it should seek to boost exports through standardisation and quality assurance. He said the label "Made in Pakistan" must be the symbol of quality and arouse confidence in the product. The President said that "our new regulator DRAP needs to facilitate the Pharma industry in promoting quality." The President urged for adopting corporate culture within the regulatory system, and emphasised that regulatory decisions needed to be taken in a transparent manner with all stakeholders on board.
He said that in view of globalisation of trade, being the double edged, "we can progress only if we are better prepared for the competition. Let us pledge to make our Pharma industry a truly global industry," the President said in his speech. He said that with the availability of cheap labour, necessary skills and other opportunities in the international markets, there was no reason why our pharmaceutical companies could not distinguish themselves in the international markets. The President, on the occasion, complimented Dr Firdous Ashiq Awan and her team, especially Dr Suhail Siddiqui for their commitment and untiring efforts towards materialising of such an important legislation.
The President also distributed awards among various Pharmaceutical companies who have achieved distinction in various Pharma related fields. Minister for National Regulations and Services Dr Firdous Ashiq Awan also spoke on the occasion and highlighted various feature of the law and the achievements of pharmaceutical sector of the country.-PR
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