CONTRACT MANUFACTURING

Due to lack of incentives and policy direction from the government, pharmaceutical industry has not been able to tap the full potential of USFDA approved plants until now. Allowing Contract Manufacturing for an unlimited period is a simple yet effective initiative government can take to boost exports. Instead of defining a term limit for contract manufacturing, licenses should be awarded to only those pharmaceutical companies that adhere strictly to the cGMPs (current Good Manufacturing Practices). This would eliminate any quality standard differences in Pakistan, allowing only the products that conform to international standards.

Government must encourage Contract Manufacturing, as it will:

o encourage technology transfer to Pakistan
o provide predictability and remove uncertainties
o support long-term commitments, which will ultimately ensure continuous supply of quality drugs to the patient
o allow utilization of idle/available capacity resulting in cost reduction and local investment. As economies of scale would make many drugs to be produced and sold at low prices.

For increasing exports, Pakistan will have to invest in getting certifications from USFDA, WHO, EMA, MHRA. This requires implementation of Good Manufacturing Practices (GMPs) and Good Packaging Practices (GPPs) that comply with international standards. In 2017, Pakistan’s pharmaceutical exports were around USD 212 million that were 6.6% of the total revenue of pharmaceutical industry in Pakistan of USD 3.2 billion. Whereas, India’s pharmaceutical exports of around USD 16.4 billion, having a contribution of 50% to the total revenue of the pharmaceutical industry revenue.

Trade policy 2005–06 states that TDAP will meet 50% cost of audit/accreditation by international health regulatory bodies. But TDAP has not assisted any company in getting accreditation from international regulatory bodies.