PPMA urges PM to sign pending summaries for drugs to stop strangling of the industry

KARACHI: In a press conference convened by the Pakistan Pharmaceutical Manufacturers’ Association (PPMA), they have urged the prime minister to take time out forthwith from his pressing political engagements to sign summaries sent by the Drug Pricing Committee last year as critically ill patients have been acutely suffering owing to his indecision.

Central Chairman of PPMA Dr. Kaiser Waheed flanked by key office-holders of the association made this demand while addressing a press conference here on Wednesday.

“This is like our last resort to earnestly request the prime minister to sign these summaries as otherwise there would be no respite in near future for patients suffering from acute ailments like Hepatitis C or renal failure as some 100 important medicines have become short in the local market owing to delay in approving recommendations of Drug Pricing Committee sent last year,” said Dr. Waheed.

The PPMA chairman said that ideally speaking such matters should have been dealt at the level of the Drug Regulatory Authority of Pakistan (DRAP) without sending them at the ministerial level and later on to the PM House.

Such unprecedented delays is the prime reason why PPMA and of the entire Pharmaceutical industry have been the consistently demanding to grant complete autonomy to the DRAP to regulate entire affairs of the Pharma sector like any other regulator related to other segments of the trade and economy, he said.

“We very well know the present pressing pre-occupation of the prime minister but what else we could do, where else we could go and make our demand when critically ill patients of fatal ailments like Hepatitis C and renal failure have been acutely suffering due to shortage of essential medicines to treat them,” he said.

Dr. Waheed said that production and availability of a number of essential medicines, life-saving drugs, new and orphan molecules in Pakistani market had been severely affected due to indecision of the PM.

For instance Hepatitis C patients in Pakistan have yet to get access to Daclatasvir a tablet, which contains miraculous-like cure for people suffering from this fatal disease that was earlier considered incurable.

Then patients of renal failure on dialysis could not get tablets to maintain desired level of vital Amino acids in their body as these are medicines whose unavailability in the local market simply means that fundamental rights of large number of patients in the country are not being fulfilled by the State, he said.

He said that a few months back a delegation of the PPMA had met President Mamnoon Hussain and urged him to play his role in this regard but he too expressed his helplessness by responding that the Pharma industry should start manufacturing these essential medicines by incurring loss.

“We should keep in mind that medicines producers are commercial and business institutions as they could not do their manufacturing on such a large scale without taking into account commercial viability of their products,” he said.

Dr. Waheed on the occasion also raised the issue that an undue and illegal system of “Panel inspection” had been imposed on the Pharma industry, which used to apply to the Registration Board of the DRAP for introduction of any new medicines in Pakistani market.

He said that systems like Panel inspection would only delay manufacturing and introduction of new medicines in the Pakistani market as such people were made part of the so-called panel inspection teams who had no idea at all about good manufacturing practices of the Pharma industry.

Moreover, he said that barcode system was being introduced for selling of medicines in Pakistani market, which would be an exercise in complete futility as here shopkeepers were in the practice of selling a very few tablets on the demand of patients instead of selling the whole blister pack.

He said that billions of rupees had been lying unused in Central Research Fund maintained by Health ministry as Pharma companies had been contributing one per cent of their gross profits towards this fund since 1976 for doing research for development of new medicines. The industry on alternative basis should get access to this fund for purely utilizing the unused capital for its own growth especially from point of view of exports-related requirements, the PPMA chairman demanded.

In future the government should stop forthwith extortion from medicines manufacturers in the name of maintaining this so-called Research Fund, which had been of no use so far, he said.

Dr.  Waheed said it was high time that the DRAP should completely waive or significantly decrease highly exorbitant fee prescribed for all sorts of documentation and bureaucratic procedures required for exports of medicines from the country.