Health crisis anticipated as DRAP restricts contract manufacturing

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Salim Ahmed

The Drug Regulatory Authority of Pakistan (DRAP) is trying to reinvent the wheel by discouraging a global practice of toll/contract manufacturing creating fuss specifically for the pharmaceutical companies and causing shortage of quality low priced medicine 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, seasoned economist, and added that the MNCs will be forced to import the drug and this will result in substantial loss to the local economy and would increase the drug prices which poor patients cannot afford.
‘The DRAP is issuing licenses for toll manufacturing only for three months instead of two years, this is just to create hurdles for the companies that are in this practice which is not good for the industry and patients,’ said a source at local pharmaceutical industry requesting anonymity.
He claimed that instead of looking after its core job of ensuring quality of medicine, the DRAP, envisioned on pattern of global pharma regulatory bodies, is deviating from its course and entering into useless debates on whims of few resulting in jeopardizing the production of low priced drugs which multinational companies get produced at local companies’ plants.
He added that this will further slow down the availability of lifesaving drugs that are already facing 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 DRAP on toll manufacturing will further burden the companies,’ added Dr. Praveh.
He further added that toll manufacturing is a global practice but here in Pakistan DRAP is working according to its own set rules which are contrary to the global practices. ‘Pick and choose policy by DRAP rather than a transparent and open policy is in practice here since long. It is strange why they always try to create hurdles for pharmaceutical companies which in turn make the patient suffer,’ he reasoned.
He said that DRAP is already overburdened with pricing and registrations issues on top of it, it has added another cumbersome process of renewing licenses 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 are 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 the domestic pharmaceutical firms practicing best manufacturing practices,” said a local pharmaceutical manufacturer. He said that many multinational pharmaceutical concerns that were forced to wind up their manufacturing facilities due to pricing issues with the DRAP accorded permission to the local pharmaceutical concerns 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 recognized medicines. It offers flourishing avenues for local industries and creates employment opportunities for many.
“This issue was also raised inMcKinsey Consultants Pakistan Business Plan forthe 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 optimize 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).
Instead of implementing these recommendation the DRAP, it seems, has decided to disallow outsourcing altogether.
dustry rather than creating issues or disappointing the players due to thoughtless policies because they know how important good favorable policies are for the prosperity of a country.
‘The DRAP should work on devising an open policy for the benefit of both the industry and the patient. Having good policy in place will result in new employment opportunities and growth for the pharmaceutical industry,’ he added.