US Human Services Secretary Michael Leavitt has offered his government’s assistance to Pakistan in drawing up pharmaceutical legislation and establishing a drug regulatory authority. Despite Pakistan’s soaring pharmaceutical exports, there is currently not a single manufacturing unit in the country which has been approved by the US Food and Drug Administration.

Sec Leavitt’s offer came during meetings this month with Pakistan’s Prime Minister Syed Yousuf Raza Gilan and Health Minister Sherry Rehman, during which he said the USA would be interested in sharing its expertise and best practices for the setting-up of a regulatory agency.

Pharmaceutical exports from Pakistan have soared 30% in the last year and currently stand at around $274 million annually, according to various estimates. The industry sells its products to 52 overseas countries, its major customers being African nations, central Asian states, the Philippines, Vietnam, Myanmar and Sri Lanka.

According to local industry leaders, this fast growth is due to aggressive marketing by domestic drugmakers and also because they have been bringing the quality of their production more into line with international standards.

However, while all other industries in Pakistan come under the administrative control of the Ministry of Industries, the fact that the pharmaceutical sector is the responsibility of the Health Ministry has held the sector’s development back because has no expertise in promoting the sector internationally, say industry figures. In addition, pharmaceutical raw materials and packaging materials are current too heavily taxed, they say.

Sales of medicines on the home market in Pakistan totaled something over $1.4 billion last year, or less than $10 per head, but the total should increase to more than $2.3 billion by 2010, a recent report by Research and Markets has forecast.

- Earlier this year, Sec Leavitt had told the government of India that the FDA “would be glad” to provide it with “technical assistance” in setting up a Central Drug Authority of India (CDAI) based on the FDA, and could even open an office in the country. The US agency is also working with the authorities in China with the aim of having FDA offices and inspectors operating in Beijing, Shanghai and Guangzhou by the end of this year.

Last November, the US Government Accountability Office (GAO) reported that the FDA inspects only around 7% of the total number of foreign drug manufacturers believed to be supplying the domestic market. Moreover, the agency was unable to provide inspection records for two-thirds of the 3,250 facilities worldwide that provide pharmaceutical ingredients to the US, it said.