PPMA dismisses new Punjab Drugs Amendment Ordinance 2015September 16, 2015
KARACHI: Pakistan Pharmaceutical Manufacturers’ Association (PPMA) has completely rejected the newly promulgated Punjab Drugs Amendment Ordinance 2015 and called for its repeal. It assured the government its full support to conduct crackdown against spurious drugs under Drug Act 1976.
Addressing at an urgently called press conference here on Thursday, Central Chairman of PPMA Saeed Allahwala, accompanied by members of central executive committee of representative body of drug manufacturers, called upon the government to immediately withdraw the ordinance promulgated as it had virtually diminished the long existing distinction in the country between licensed manufacturers of drugs and those producing their counterfeits.
The PPMA chief said that the recently promulgated ordinance in Punjab had created a situation of serious commotion and uncertainty among licensed manufacturers of medicines as under this new law they were being dealt in the same harsh manner similar to actions against unscrupulous elements indulged in production of spurious drugs in the country.
He said the new provincial law prepared in haste had meted out sheer unfair treatment to a national level industry comprising 600 companies who had been ably fulfilling up to 90 per cent requirement of medicines in the country while owing to its operations, Pakistan continued to have a functional health system.
He said that services of this pharmaceutical industry of Pakistan had been acknowledged in various other countries while the new ordinance had not only created serious suspicions among consumers of the industry within the country but also had sent a strong negative impression in export markets for Pakistani medicines.
He said the massive advertising campaign launched last some month with enactment of this new drug law had sent the utterly wrong message in medicines markets worldwide that up to 45 per cent drugs manufactured in Pakistan were spurious.
Mr. Allahwala said the new ordinance had been highly undue in presence of frameworks available to the govt under the Drug Act and Drug Regulatory Authority of Pakistan (DRAP) Act-2012 to effectively check and counter production of counterfeit medicines on a nationwide basis.
He said it was unnecessary for a single province to exclusively enact a special law for the purpose when system against production of spurious medicines should work at the countrywide level.
He said that licensed producers of drugs on worldwide basis were warned and penalized under systematic laws and regulations for defective and substandard production of medicines but nowhere in the world the pharmaceutical industry was subjected to such harsh laws giving arbitrary powers of doing crackdown to drug inspectors.
“In the USA alone some 25,000 samples of medicines are recalled every year by the authorities for defective manufacturing while here in Pakistan some couple of years back the govt had chosen 85,000 samples of medicines for checking their quality and standard but only three of them were found defective,”.
The PPMA chairman said that with prevailing stringent industry standards and regulations being maintained under Drugs Act and DRAP law, there had been no use of promulgating a provincial level ordinance against spurious drugs.
He said the new Punjab Drug Ordinance had been drafted and promulgated in sheer violation of policies of present government and its Vision-2025, which had clearly envisaged that no law should be enacted in the country without consulting and taking onboard the concerned industries. “While the govt had not consulted us at all while enacting this new law, which had been imposed in haste seemingly out of sheer frustration of Punjab chief minister against prevalence of spurious medicines in local markets,” said the PPMA chief.
He said the Rs 250 billion pharmaceutical industry of Pakistan, with over 200 million US Dollars exports in 2014 with international acceptability in many markets globally, had done some excellent contribution to pressing socio-economic causes of the country as it always responded well every time Pakistan had faced any situation of natural calamity so to mitigate sufferings of disaster-hit population. “This ordinance should be repealed so as to give due chance to pharma industry of Pakistan to operate and flourish,” he said. Mr. Allahwala said the new ordinance by Punjab govt was also not at all in line with any set of global health and drug standards defined by worldwide regulatory bodies including the World Health Organization.
He said the pharmaceutical industry had all the resolve to sit with the govt to devise a systematic and well-regulated mechanism against production of spurious drugs but the government as the first step should stop annoying licensed manufacturers of drugs in the country.
Also speaking, former chairman PPMA Zahed Saeed said that with promulgation of new ordinance in Punjab, the pharmaceutical industry in Pakistan had been facing very vague situation while fearing sudden crash exports of its licensed products to international markets.
He said the government should first make its existing system of regulating the drug manufacturing more stringent and active and in this regard, no hindrances should be posed in the way of working of manufacturers of genuine drugs.