Inquiry ordered against DRAP for ‘inordinate’ delay
MUSHTAQ GHUMMAN
ISLAMABAD: The federal cabinet has ordered a probe against Drug Regulatory Authority of Pakistan (DRAP) for “inordinate” delay in registration of local manufacturing of drug by a Pakistani pharmaceutical company, under licence from Gilead, USA, to give benefit to the importers, well-informed sources told Business Recorder.
On June 16, 2020, National Health Services, Regulations and Coordination Division informed the federal cabinet that Section 12 of the Drugs Act, 1976 and the Section 7 (c) (vii) Drug Regulatory Authority of Pakistan Act, 2012 empowered the Federal Government to fix Maximum Retail Price (MRP) of a drug to be sold in the market. Further, drug price fixation mechanism had been detailed in the Drug Pricing Policy-2018.
The sources further said that based on earlier approval of the United States Food and Drug Administration (FDA), European Medicine Emergency (EMA), Medicine and Health product Regulatory Agency of (MHRA) of the UK and Pharmaceutical and Medical Devices Agency (PMDA) of Japan, Registration Board of DRAP approved emergency use authorization for Remdesivir 100mg injection/ vial to two importers and 14 local manufacturers in its meeting held from June 8, 2020 to June 11, 2020 of supply to healthcare facilities dealing with Covid-19 patients under strict supervision of qualified specialist physicians. Before issuance of registration letters to applicant companies retail price had to be proposed to the federal government under section 12 of the Drug Act, 1976, which is the function of the Drug Pricing Committee (DPC) in DRAP under authority of SRO No. 707(1)/2013 of August 5, 2013. The drug pricing policy committee held a special meeting on June 12, 2020 to recommend Maximum Retail Price (MRP) of Remdesivir Lyophilized Powder for injection 100 mg/injectable solution 100mg vial.
The committee noted that the paragraph 4(1) of the Drug Pricing Policy, 2018 provided for MRP fixation of Originator Brand of New Chemical Entities (NCEs). However, originator brand of Remdesivir developed by M/s Gilead Sciences Inc. USA was being supplied to hospitals only in the USA and was not available for export to Pakistan. Under the policy, if an MRP of originator brand of NCE is not available, MRP of generic substitutes in India and Bangladesh as verified under the procedure vide paragraph 4(3) of the Drug Pricing Policy 2018.
It was noted that the price information for the drug in not available on official website of National Pharmaceutical Pricing Authority of India. The committee also informed that the High Commission of Pakistan in Dhaka in its letter of June 7, 2020 had communicated that Bemsivir (Remdesivir) manufactured by Beximco Pharmaceuticals was available in Bangladesh and could be legally exported to Pakistan at a price of $ 66. It had been further informed by the High Commission of Pakistan in Dhaka that price of the drug may come down by the end of this month to $ 50-55 depending on change in prices of raw material.
Accordingly, on the basis of the position communicated by Pakistan High Commission in Bangladesh, the DPC on June 12, 2020 as per paragraph 4(4) read with paragraph 12(5) of the Drug Pricing Policy, 2018 made recommendations which were submitted for consideration of the federal government as follows; (i) MRP of Remdesivir Lyophilized power for injection 100mg/injectable solution 100mg vial on generic basis may be fixed at Rs 10,873/US $ 164.744; (ii) Customs Duty/Additional Customs Duty and Income Tax at import stage may be reduced to zero on import of finished drug Remdesivir 100mg injection/injectable solution 100mg vial; (iii) According to the information shared by Pakistan High Commission in Dhaka, it was expected that the price may come down to $ 50-55 depending on change in the prices of raw material. The price of Remdesivir Lyophilized powder for injection 100 mg/injectable solution 100 mg vial would be reviewed as soon as the relevant information in price change is shared by the High Commission in Dhaka. DRAP would keep regular liaison with High Commission of Dhaka in this regard.
The registration letters could only be issued to applicant companies after approval/ notification of MRP by the federal government. There was an urgent need to make this drug available at healthcare facilities to save human lives.
During a discussion, the cabinet members drew the attention of the forum to the reports of “inordinate” delay by DRAP in registration of local manufacturing of drug by a local manufacturer under licenced from Gilead, USA, allegedly to give benefit to the importers. Keeping in view the emergent Covid-19 situation in the country, the members suggested to approve maximum retail price for Remdesivir 100mg injection but opined that a probe into allegations against DRAP must be carried out.
After a detailed discussion and approval of maximum retail price of Remdesivir 100 mg injection, cabinet directed that Secretary, National Health Services, Regulations and Coordination Division, shall conduct an inquiry to determine the veracity of allegations of “advertent” delay in registration of local manufacturing of drug by this local pharmaceutical company, under licence from Gilead, USA, to give benefit to the importers.
