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No FDA-approved pharmaceutical plant in Pakistan SBP

No FDA-approved pharmaceutical plant in Pakistan: SBP

KARACHI: Pakistan, with a population of 200 million, does not have a single pharmaceutical plant that complies with the standards prescribed by US Food and Drug Administration (FDA), the annual report of the State Bank of Pakistan notes.

The SBP annual report 2015-16 goes on to add that in sharp contrast, Jordan with a population of only 17 million people has three FDA approved plants. The size of Jordan’s pharmaceutical industry is $1.5 billion with exports of $1bn while Pakistan’s pharma industry is worth $2bn dollars with exports of $208 million.

The FDA, a US agency, is responsible for “protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods and feed and veterinary products”.

Having FDA-approved plants allows pharma companies to make inroads into market of advance economies.

According to the report, India’s population is 1.3 billion with the industry worth $26bn and exports of over $12bn. India has 201 FDA approved plants.
India has 201 and Bangladesh has five plants approved by the US agency

In contrast, Bangladesh with a population of 170 million has five FDA approved plants with industry size of $1.5bn and exports of $70m.

Chairman Pakistan Pharmaceutical Manufacturers Association (PPMA), Dr Kaiser Waheed said there are 770 licensed manufacturers and 24 multinational companies (MNCs).

“No Pakistani company is FDA approved,” he said, adding the reason is economy of scale.

To set up an FDA approved plant, at least $300m is required, he said. Besides, another problem is inconsistent government policies as well as no drug policy and lack of competent human resource.

“As far as I know, no Pakistani company has applied to the FDA. MNCs have their corporate reasons for not having FDA approved plants in Pakistan. As it is, MNCs are planning to leave Pakistan soon,” Dr Kaiser said.

Executive Director Pharma Bureau (PB), Ayesha Tammy Haq said obtaining FDA approvals requires investments in systems and staff. The main reason for not having FDA approved plants in Pakistan in mainly due to price regulation of all molecules.

“In India and Bangladesh, price is controlled for only those essential drugs which are deemed essential, with the rest being uncontrolled. This gives leverage for companies to invest in certifications and hence boost exports,” Ms Haq said.

To change the situation, the government needs to reevaluate its policies and revise them to stimulate investments in certifications and improvement in quality, she added.

Courtesy : Dawn News

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