Over 2,000 pharma firms loses DRAP’s registration

MN Report

Lahore: As many as 2,000 pharmaceutical companies of a total 4,000 firms, despite losing their DRAP’s (Drug Regularity Authority of Pakistan) registration continuing marketing of their products and yet go unpunished.

It may be pointed out that the DRAP has recently rejected registration of around 2,000 pharmaceutical companies, restricting production of over 36,500 drug items in the country.

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 relating to drug prices, licensing and inspecting drug manufacturers, and drug registration for local manufacturing or imported medicines.

However, sources said that Punjab govt which is required to implement the DRAP’s directives has repotedly failed to check illegal manufacturing of drugs in province.

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 issued licence to continue manufacturing of their products so far, whereas remaning companies’ licences will either be granted or rejected by Dec 31, 2015.

Sources in the industry claimed that Punjab government, instead of taking action against the companies whict lost registration for not meeting standards set by the DRAP, was creating hurdles in the operation of registered companies possessiong 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 the actions against unscrupulous elements who were indulging 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 the country’s parmaceutical industry had been acknowledged in various countries, while the new ordinance had not only created serious suspicions among consumers of the industry within the country but also had sent a negative message in export markets for Pakistani medicines.

They demanded of 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.

“In fact, the new provincial ordinance does not make sense in the presence of frameworks available to the government under the Drug Act and DRAP Act-2012 to effectively check and counter production of counterfeit medicines on a countrywide basis,” sources said, saying 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 across the country.

Sources in Punjab pharma industry, who wished not to be quoted, said 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 huge export potential.

They deplored that no multinational has, at present, introduced new research-based medicines which  their parent companies have introduced globally.
Claiming that there are only 14 drug inspectors in the country to monitor over 600 manufacturing facilities, they asked that how it was possible to ensure the quality of drugs with such a small number of drug inspectors.

With regard to profitability of the pharma industry, the sources claimed that it was only 2pc as against tobacco industry’s around 70pc. The low margin of profit has forced several multinationals to leave the country, they added.