LAHORE: The Drug Regulatory Authority of Pakistan (DRAP) is allegedly discouraging the global phenomenon of toll (contract) manufacturing, which is creating unrest in the pharmaceutical manufacturers, and causing shortage of quality low priced medicines in the country.
“If the foreign companies find it difficult to have their products made at local plants they will simply shut down the production hampering local companies’ investments and putting thousands of jobs at risk,” said Dr Pravesh Kumar, a seasoned economist, and added that the multinational pharmaceutical companies (MNCs) would be forced to import drugs, which would result in substantial loss to the local economy, besides increasing drug prices.
‘The DRAP is issuing licences for toll manufacturing only for three months instead of two years, which is not good for the industry and patients,” said a source in the local pharmaceutical industry, requesting anonymity.
Dr Kumar said that instead of looking after its core job of ensuring quality of medicine, the DRAP, envisioned on pattern of global pharma regulatory bodies, was entering into useless debates on whims of few resulting in jeopardising the production of low priced drugs, which multinational companies get produced at local companies’ plants.
He added that it would further slow down the availability of lifesaving drugs that were already facing an acute shortage due to pricing issues. “Companies have already reduced the production of many important life saving drugs because they are incurring losses on them. Now this restriction from the DRAP on toll manufacturing will further burden the companies,” added Dr Kumar.
He said that the DRAP was already overburdened with pricing and registrations issues, and on top of it, it had added another cumbersome process of renewing licences for toll manufacturing for only three months and that too after a lot of hue and cry from both foreign and local companies. He added that a fast track registration on which thrice the normal fee is charged, companies were waiting since February for their cases to be finalised even after paying his fees.
“It is indeed a fact that in order to save costs, many reputable companies, particularly multinationals, have outsourced their products to domestic pharmaceutical firms practicing best manufacturing practices,” said a local pharmaceutical manufacturer. He said that many multinational pharmaceutical companies that were forced to wind up their manufacturing facilities due to pricing issues with the DRAP accorded permission to the local pharmaceutical companies to manufacture those drugs in the country so that patients continue to have access to quality medicines. “On the other hand it ensures the affordability of internationally recognised medicines. It offers flourishing avenues for local industries and creates employment opportunities for many.”
“The issue was also raised in McKinsey Consultants Pakistan Business Plan for the Planning Commission of Pakistan in March 2010,” said an industry expert. He said the DRAP grants two years’ permission to any firm for outsourced drugs. He said the McKinsey Report recommended the government of Pakistan to allow companies to optimise production configurations (and thereby lower manufacturing costs) by subcontracting manufacturing to other companies indefinitely (versus 2 year limitation at that time which continued till now).
“This will spell disaster for the pharmaceutical industry in Pakistan and create problems for a large number of patients,” said an industry expert. “Currently there are around 200 highly consumed medicines that were being manufactured by the domestic companies on permission of renowned global manufacturers.
“They are not realising that their haphazard policies since long are conducive in making international pharmaceutical companies leave the country only. The sad thing is that quite much damage has been done to the pharma industry due to such policies but the regulator is still the same and coming up with new ideas of hurting the industry,” he added.
“The DRAP should work on devising an open policy for the benefit of both the industry and patients. Having good policy in place will result in new employment opportunities and growth for the pharmaceutical industry,” he said.
