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National Drug Regulatory Authority (DRA) Need of the Time

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Lahore (PR): Recent events have clearly shown that there is an urgent need for the Formation of a National Drug Regulatory Authority (DRA) that must work with the pharmaceutical industry to establish a transparent regulatory framework focused on the provision of quality healthcare for all. This was disclosed by President Business Forum of Punjab Ibrahim Qureshi in a press conference here yesterday.

President Lahore of Business Forum of Punjab Mian Asad Shuja ur Rehman, Senior Vice President Lahore of Business Forum of Punjab Khawaja Shahzeb Akram, office bearers of Business Forum and Pharmaceutical Manufacturers Association were also present on this occasion.

Mian Asad Shuja ur Rehman along with Mr. Ibrahim Qureshi reviewed the current pharmaceutical business ratio in the whole business set up of the country. They said that Pakistan has a vibrant and forward looking pharma industry, from neither manufacturers nor traders in 1947, Pakistan today has about 526 manufacturing units, the value of pharmaceuticals sold in Pakistan in 2011 was approximately USD 1.8 billion – a per capita consumption of less than USD 10 per annum, with average growth of 18% per annum. They said that pharma industry has been a neglected industry and the victim of an adverse and discriminatory regulatory framework which has hindered the industry in achieving its true potential.

Ibrahim Qureshi said that on the other hand, the Indian pharma industry supported through a pro-industry regulatory framework has emerged as a global player – without compromising on patient needs.

Khawaja Shazeb Akram while addressing the media men said that the contribution made by the industry is very notable. He said that the industry meets 90% demand of finished medicines and in the process saves the national exchequer several billions of dollars through import substitution. The competitive pressure from a large and growing number of national manufacturers ensures that drug prices remain affordable for the masses. The Industry has ensured availability of pharmaceutical products in wars, earthquakes and floods. The industry provides direct and indirect employment to nearly 6.5 million people in the Country. National Pharma companies continue to invest heavily to upgrade itself and today possess the capacity to manufacture a variety of products ranging from simple pills to sophisticated biotech and value added generics.

Kh Shahzeb Akram also briefed about the Vision 2020. In 2011: Export revenue was of USD 200 million, with average yearly growth of 29%. To achieve medicines export a target of US $ 1 billion by 2020 is set. Pharma import bill to be reduced to only 10% of total Pharma market demand. At least 15 national companies to achieve WHO GMP certification and 20 companies to achieve EU/UK accreditation; and 5 companies to achieve US/FDA certification.

Mian Asad Shuja ur Rehman added that Drug Regulatory Authority is needed in Pakistan to maintain same standard of quality control of medicines all over Pakistan, so as to have one window operation for better & effective mechanism for medicine. In order to maintain standard procedures for registration of medicines all over Pakistan thus elimination the chances of similar brand names of different chemicals in various provinces of Pakistan. Also to ensure imports and exports of medicines through one window operation at federal level since imports and exports are federal subjects, Khawaja Shazeb Akram said that to ensure quality & efficacious medicines availability in Pakistan & ensuring quality medicines exports, and to avoid shortages of life saving medicines in country, we need DRA be established at the earliest..

Ibrahim Qureshi added that Pharmaceutical Industry is a highly specialized and regulated Industry that requires coordination by an Independent Central body which in the case of medicines is the Drug Regulatory Authority (DRA). The Pharma Industry is one of the success stories of Pakistan – and can be an even greater success story in the near future. Khawaja Shazeb Akram said that despite being neglected by the Government and despite of discriminatory policies, the industry has not only survived but is at a stage where with a conducive regulatory framework it can perform an economic miracle for Pakistan.