ISLAMABAD – Striking back with equal force, the Drug Regulatory Authority of Pakistan (DRAP) vehemently denied the allegations levelled against it by the Pakistan Young Pharmacists Association (PYPA) and Pakistan Drug Lawyers Forum (PDLF), and has demanded that an investigation be conducted to unveil the vested interests of drug lawyers and pharmacists.
“In a desperate attempt to gain vested interests and to pressurize DRAP officials, these elements are disseminating misleading information to divert the focus of regulators and investigational agencies from their heinous crimes. The Ministry of Health and DRAP refute all allegations, which are factually incorrect and misleading. These elements are aggrieved due to improvements in functioning of DRAP in line with international regulatory practices and numerous campaigns to eradicate spurious, fake and illegal drugs,” DRAP has counter-alleged through a press release issued most recently.
The press release then lists some of the new initiatives taken to streamline the drug registration process for provision of quality drugs. These measures include international quality Common Technical Document (CTD) format for drug registration dossier, 2D bar-coding on labelling, mandatory Good Manufacturing Practices (GMP), certified source of raw materials of Active Pharmaceutical Ingredients (API) and excipients, and standardisation of drug specification, etc. “We will not accept any pressure and will take stern action against all mafias spreading spurious, fake and counterfeit drugs,” DRAP has warned.
DRAP has further clarified that the Supreme Court of Pakistan has upheld DRAP’s decision for cancellation of registration of Recombinant Bovine Somatotropin (RBST) hormones and has vacated the stay granted in this respect by the Sindh High Court. Accordingly, the Quality Assurance Division of DRAP has issued directives for stern action against sale of RBST hormone, which was being used to increase milk production in cattle.
“The federal inspectorate and provincial inspectors are conducting raids and have ceased stocks of banned injections. However, certain elements are deliberately trying to confuse the cancellation of registration of RBST with other drugs, oxytocin in particular, which is used in cattle and pets for precipitation of labor and control of uterine hemorrhage,” DRAP has stated.
DRAP has also maintained that the World Health Organization has issued a position paper in which the dengue vaccine has been conditionally recommended for use in areas where dengue is prevalent. “However, dengue vaccine shall be prescribed in seropositive patients after getting results of proper diagnostic tests. In Pakistan, due to high prevalence of dengue, the Registration Board has approved the registration of dengue vaccine, which is in process of price fixation by the federal government,” the press release adds.
Responding to allegations of embezzlement of records, DRAP has termed these as “totally baseless,” and has added that on the contrary, decades’ old manual registration record has been computerized and a provisional database has been uploaded on its official website. “None of our record is missing or lost,” DRAP has maintained.
Regarding drug pricing, DRAP has pointed out that a stringent mechanism has been provided under the Drug Pricing Policy 2015, which is being implemented in true spirit. The Drug Pricing Committee recommends price fixation as per policy, which is further re-scrutinized and finally decided by the federal cabinet.
Referring to the case of Dr. Sh. Akhter, DRAP has maintained that since the referred letter is from NAB, and not from the Ministry of Health or DRAP, it cannot comment on it. “Furthermore the matter is sub judiciary, and bringing it to the media is an attempt of contempt of court,” the press release adds.
DRAP has dubbed all allegations as a desperate attempt on part of certain elements to create confusion among public and has demanded that the said elements be investigated and their activities be checked. “These elements through their official contacts, are constantly misguiding high public offices, public agencies, establishment and court of laws, so as to pressurize honest officers who have dared to take actions against such culprits,” DRAP has counter-alleged.