Islamabad - Drug Regulatory Authority of Pakistan (DRAP) on Thursday, denying the allegation regarding non-registration of Hepatitis C medicine, said that the drugs were freely available in the market.

The Ministry of National Health Services & Regulations (NHS) and DRAP are at lock horns with two associations naming Pakistan Drugs Lawyers Forums (PDLF) and Pakistan Young Pharmacists Association (PYPA).

The associations had alleged that DRAP is avoiding registration of hepatitis medicine to favour a specific group.

PDLF and PYPA had accused DRAP officials for intentionally making artificial shortage of life saving medicine in the market, price of stents and non-registration of hepatitis medicine in the country.

The ministry, in the statement issued, said that 19 pharmaceutical companies providing Hepatitis C medicine were registered and the drugs were available freely in the market.

As per statement, Hepatitis C drugs produced in the country are mostly generics while multinational companies only brought the new drug in past.

DRAP in 2015, proposed a revised requirements for the local manufacturers for data submission including the stability studies based on scientifically rational laboratory scale batches instead of larger pilot scale batches.

Registration Board in its 251st meeting held in August, 2015 approved procedure to be followed in future for all new drug generic versions which helped local firms to complete the required data and their registration application.

NHS, denying the claims of association regarding registration of medicine, also responded that approval of registration could not be done overnight and it requires a procedure.

“The claim that registration board should grant approval is irrational, unscientific and against the law and it is not practiced anywhere in the world without proper evaluation and confirmation,” said statement.

Proper evaluation and confirmation was done in case of Sofosbuvir, a medicine for Hepatitis C, statement said.

New chemical entities namely; Daclatasvir, Ledipasvir and Velpatasvir new drug generic versions for the treatment of Hepatitis-C have already been approved for registration by the Registration Board through similar onsite inspection, verification and authentication of submitted data.

Regarding prices of stents in Pakistan, it is pertinent to mention that the prices of medical devices are not regulated in the world even in countries where the drug prices are controlled.

The DRAP has gone in appeal and also seeking opinion of law division to enable the federal government to fix prices of essential drugs as soon as possible.

As per statement any unregistered drug under patient need basis can be imported by the institutions, directly or through indenters and DRAP always allows patient or hospital to import such medicine on prescription/institutional basis as per S R O 28(I)/2013.

Under Section 6 of the Drugs Act 1976, the storage and sale of drugs in the market is regulated by the provincial governments, therefore, DRAP has advised the provincial health authorities to take action under the law against the companies who violate provisions of the Drugs Act, 1976 and rules frame there under.

The government is further working for the pricing mechanism of stents and medical devices as submitted in the Supreme Court of Pakistan. DRAP has given an advertisement on 5th April, 2017 for expression of interest for consultancy services to study/research for data for determination of landed cost, components of operating expenses in storage, distribution, marketing & sale, expenses and margin/mark-up in percentage term in supply chain of imported medical devices including cardiac stents, defibrillations, pacemakers, prosthetic heart valves and cardiac balloon catheters and suggesting for reasonable rate of profit/rate of return on investment to importers.

 

 

rahul basharat