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PR No. 155 NO ONE TO BE ALLOWED TO DERAIL REFORM PROCESS ALL RECORD BEING DIGITIZED, COMPREHENSIVE PRICING POLICY BEING IMPLEMENTS – DRAP Islamabad: April 18, 2017

In a strongly worded statement Drug Regulatory Authority of Pakistan has reaffirmed its commitment to reform saying no one will be allowed to derail the process of change. All manual system of record is being done away with and replaced with digitized record. This is a major reform measure that will improve the efficiency of the authority and enhance transparency.

The digitized record will also help in publishing Pakistan National Formulary. Similarly, the decision of allocation of fresh registration number in cases of change of registration holder, is taken to avoid possible legal complications and the old registration number will stand cancelled.

The Drug Pricing Committee recommended maximum retail prices of drugs according to the Drug Pricing Policy-2015 and in the public interest. It is baseless that prices of Daclatasvir 60mg & 30mg Tablets and Sofosbuvir + Ledipasvir 400mg/90mg Tablets were fixed higher. As a matter of fact, the committee  recommended Maximum Retail Price of Daclatasvir 60mg Tablets @ Rs.4552/28’s and Daclatasvir 30mg Tablets @2782/28’s as the lowest demanded prices by a manufacturer whose drug had been approved by the Registration Board. The recommended price of  Daclatasvir 30mg Tablets is less than half of its price in India (eq.to Pk.Rs.5909/28’s) – this strength not available in Bangladesh- and DPC recommended price of  Daclatasvir 60mg Tablets which is again less than half of its price in India (eq.to Pk.Rs.9799/28’s) & 1/4 of its price in Bangladesh (eq.to Pk.Rs.16878/28’s). Price of Sofosbuvir + Ledipasvir 400mg/90mg Tablets was recommended as per provisions of the Drug Pricing Policy-2015 which is again 29% lower than its price in India (eq.to Pk.Rs.37912/28’s) and less than half of its price in Bangladesh (eq.to.Pk.Rs.66928/28’s). Under no circumstance, demanded prices by a company whose drugs have not been registered by the Registration Board can be considered as benchmark.

Prices of drugs of M/s Otsuka have not been increased during last 5 years and information being provided by some elements in this regard is baseless. In 2011, after devolution of Ministry of Health, almost all six (6) manufacturers of Intravenous (IV) solution increased prices of their drugs and managed to obtain stay orders from the Lahore High Court. The Cabinet Division (Drug Control Administration was under administrative control of Cabinet Division after devolution of the Ministry of Health) contested the cases in the High Court and the Honourable Court directed through Deputy Attorney General to resolve the matter. Accordingly matter was placed before the Drug Pricing Committee (DPC) under the Chair of Secretary, Cabinet Division and IV manufacturers (including Otsuka) appeared before the DPC and explained that due to steep increase in cost of inputs, expenses of IV drugs viz, Polyethylene, Dextrose, Sodium Chloride, Sodium Lactate, activated carbon, cartons, electricity, gas, diesel, freight, minimum wages etc, it had become unviable to produce and market these drugs at previous prices. DPC, after considering all facts, decided to reduce prices of de-controlled IV drugs which were increased by IV manufacturers to unjustified level (after obtaining stay orders from the honourable court) and increased prices of controlled drugs up to justified level.

 

 

The Central Licensing Board is an independent statutory body set up by the Federal Government under Section 5 of the Drugs Act, 1976 and consisting of representatives of the Federal Government and the provincial governments. Rule 8 of the Drugs (Licensing, Registration & Advertisement) Rules, 1976 provides composition of the Board whereas rule 10 of the said rules provides procedure for Central Licensing Board for conducting its business. Rule 13 of said rules provides exclusively procedure for renewal of Drug Manufacturing License (DML). The case of M/s Otsuka Pakistan, Hub-Balochistan for renewal of their DML was considered and decided by the Central Licensing Board purely on the merit and as per provisions of law as narrated above. The allegations leveled are totally baseless and not based on facts and are, therefore, strongly rebutted.

Elements involved in heinous crime of illegal manufacturing of banned sex drugs and unauthorized manufacturing of unregistered drugs and violation of licensing rules. Whenever, actions were initiated by DRAP against these elements, they attempt to pressurize officials of DRAP and Ministry, for their vested interests, the statement concluded adding that there will be no compromise on the reform process.

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