Pharma industry opposes drugs authority's devolution

The chairman of the Pakistan Pharmaceutical Manufacturers Association warned on Thursday that the pharmaceutical industry will launch a protest drive if the regulatory regime for manufacturing and sale of medicines were devolved from the federal to provincial level.
Speaking at a press conference, Dr Kaiser Waheed said that there will be chaos in the medicines market if the Drug Regulatory Authority were devolved to the provinces, thus allowing each province to create its own drug regulatory authority. Patients would be the ultimate sufferers if this happened. He predicted that Punjab would be the first provincial government to make such a move if the government carried out its decision.
Dr Waheed referred to the Punjab Drugs (Amendment) Bill, 2017, by the Punjab Assembly passed through a majority vote on Wednesday. The bill didn't distinguish between bona fide manufacturers of medicines and those who produced spurious drugs, according to him. He said that if the provinces were allowed to establish their own drug regulatory authorities there would be turmoil in licensing, registration, pricing, marketing and in retailing of medicines.
The pharmaceutical industry is ready to support any law against manufacturing and sale of spurious drugs, he said. But if a law is adopted to make provincialize the regulation and control of drugs, "it would be deemed by us as an attempt to cause complete shutdown of our industry," he said.
He reminded that a constitutional guarantee was available to the pharmaceutical industry that there would be complete uniformity and harmony at the national level to handle the regulatory regime regarding licensing, registration, production, transportation, distribution, marketing and sales of medicines in the country. No provincial government should be allowed to alter this constitutional guarantee that ensures smooth functioning of the medicines industry, the chairman of the Pharmaceutical Manufacturers Association said. He said that the Drugs Act, 1976, empowered the provincial governments to check the sale of medicines at the retail level to prevent any wrongdoing while federal government had the power to issue licenses for manufacturing of medicines.
The federal government should retain the authority to grant licenses to manufacturing units of medicines for a uniform licensing regime is retained across the country, rather than for the authority to be devolved, he said. He warned that the pharmaceutical industry will "do whatever we can" to counter the proposed legislation whose enactment will jeopardize the existence of the pharmaceutical industry. According to him, a provincial law for a regulatory mechanism for drugs manufacturers has no precedent in any other country.
Dr Waheed said such a law would provide the provincial governments with the pretext of prevention of the sale of substandard medicines in the market. He referred to the Drugs Act of 1976 has clear provisions for dealing with the situation if spurious medicines were supplied to pharmacies. The chairman said the federal government should issue directives to prevent the Punjab government from getting the law passed. He said that only Parliament had the authority to amend the Drugs Act.