RAWALPINDI, June 17: The health ministry may lose its exclusive control over the pharmaceutical industry after a new policy comes into force, sources told Dawn here on Monday.

Under the new policy, which would be presented to President Gen Pervez Musharraf on Tuesday for approval, the health ministry will share the control of the pharmaceutical sector with the ministry of industries and production, they said.

Issues pertaining to pricing, import, export, trademark and market operations impacting supply and demand would be addressed by the ministry of industries and production.

The health ministry would focus exclusively on health- related issues, including drug registration, medicine efficacy, safety, quality stability, manufacturing facilities, standards and storage as prescribed by the World Health Organization.

The officials said the policy had been framed to attain the ultimate objective of ensuring the availability of drugs to the consumers at competitive prices.

About the issue of deregulation of drug prices, the draft policy states that the number of pharmaceutical products on the controlled list will be reduced from 313 active substances to less than 100.

The list, prepared by the industries ministry, comprises slightly over 90 molecules, whereas the list of essential drugs prepared by the health ministry contains 256 drugs.

A committee, comprising pharmacologists of leading medical institutions and a representative of the health ministry, will periodically review the controlled list and further curtail it.

According to the policy guidelines, drugs with multiple brands or those that remain in short supply because of low prices or medicines using locally-manufactured active substances would be excluded from the controlled list in future.

The companies producing drugs present on the list would be allowed annual price adjustment on the basis of consumer price index, while prices of new molecules to be added to the list would be determined at an average of the cost of the same drug in neighbouring countries.

The prices of deregulated medicines, the draft policy states, will be self-regulated by the market forces.

The proposed policy also calls for discontinuation of the chemists’ and distributors’ margin (retailer discount) and will be left to the market forces to be mutually agreed by the manufacturer and retailer.

The registration process under the new policy is likely to be simplified, which the officials state is aimed at “quickly making advances in medical research available to the consumer”.

The new medicines, irrespective of whether they are produced in Pakistan or imported from abroad, are proposed to be granted registration on the proof that the particular drug has been approved by regulators in the United States, United Kingdom, Japan and Switzerland in addition to the country of origin.

After patent expiry of a medicine, the policy proposes, fast registration of generic products on the basis of data on manufacturing facility, quality, sterility and bio-equivalence.

The policy also proposes establishment of a health and a commercial board for looking after various issues concerning the industry. The health ministry will administratively control the former board, while the latter will be controlled by the industries and production ministry.

Another important feature of the policy is that it calls for granting permanent licenses to the manufacturing units and discontinuation of the existing practice of renewing licences after every two years.