LAHORE

The Drug Regularity Authority of Pakistan has rejected the registration of at least 2,000 pharmaceutical companies, out of a total of 4,000 companies, restricting production of more than 36,500 drug items in the country. But almost all companies have been going on their operation despite losing registration, continuing marketing their pharma products without licence thanks to the carelessness of the Punjab government.

The DRAP was constituted in November 2012 after the functions of the federal health ministry were transferred to the provinces in June 2011. It is an autonomous regulatory body charged with regulating issues related to drug prices, licensing and inspecting drug manufacturers, and drug registration for local manufacturing or imported medicines.

Punjab govt the responsibility of which is to implement the directives of DRAP, keeping close liaison with it, has been failed to check illegal manufacturing of drugs in province, industry sources said.

As many as 4,000 pharma companies approached the DRAP for registration of their more than 100,000 products for enlistment from across the country but only 400 companies have been given licence to continue manufacturing of their products so far while rest of the companies will either will be granted licences or rejected by Dec 31, 2015.

The provincial government, which should have taken action against those companies, losing registration for not meeting DRAP standards, is creating hurdles in the operation of registered companies, working under proper licenses.

They 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.

The new provincial law, prepared in haste, had meted out sheer unfair treatment to a national level industry comprising 600 companies, which 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. They claimed 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. They 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.

Punjab pharma industry stakeholders, who want their name not be mentioned, stated that if the government finalises the policy as per the stakeholders’ recommendations, the pharmaceutical industry could easily grow five-fold from its current size in the next few years.

The pharmaceutical industry’s current size is around $2.3 billion with around 600 registered companies and could cross $10 billion with increased exports, which currently stand around $20 million. They said that the size of Indian pharma industry currently stands at $21 billion and is expected to cross $45 billion by 2020 due to encouragement by the Indian government in terms of a favourable policy. In Pakistan, only a conducive regulatory environment aligned with global practices could stimulate industry growth and its tremendous export potential. It is unfortunate that presently no multinational has introduced new research-based medicines which their parent companies have introduced globally, they added.

They said that there are only 14 drug inspectors in Pakistan to monitor over 600 manufacturing facilities. “How they can ensure the quality of drugs. The pharma industry’s profitability is as low as 2pc as compared to approximately 70pc for the tobacco industry. That is why several multinationals left the country and if the situation persists more will follow suit as multinationals spend heavily on research and development of new drugs, they added. Pakistan is manufacturing 80pc of the country’s medicine requirements, out of which multinationals account for 44pc.

Industry stakeholders said the new provincial ordinance does not make sense in the presence of frameworks available to the government 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. “It was unnecessary for a single province to exclusively enact a special law for the purpose when system against production of spurious medicines was already working at countrywide level.”