A parliamentary panel has directed the Drug Regulatory Authority of Pakistan (DRAP) to certify only those medicines, which are being produced at par with international standards. The Senate Standing Committee on National Health Services, Regulations and Co-Ordination, which met here on Wednesday under the chairmanship of Senator Sajjad Hussian Turi, while discussing an agenda item said that one Mohammad Riaz has filed petition with the Senate Secretariat regarding production of substandard cancer drug by Pakistan Atomic Energy Commission (PAEC).
The committee expressed serious concerns over the issue and urged the relevant authorities to take necessary steps in this connection, saying that protection of the lives should be top priority of any institution. State Minister for National Health Services, Regulations and Co-Ordination, Saira Afzal Tarar said that the government has directed the PAEC, before distribution of the drug to different cancer hospitals, it should acquire certificate of quality control and assurance from some of the international laboratories.
In his written reply to the committee, Dr Mohammad Aslam, Chief Executive Officer (CEO) of DRAP, said that the authority had thoroughly examined the matter of the complaint. "It is highly sensitive case both from organisational and related radio isotopic drugs point of view for the patient use and claimed for safety issues. This was already taken up in the Supreme Court of Pakistan by the complainant and later was withdrawn.
The complainant recently agitated the mater through the Human Right Cell of Supreme Court of Pakistan. The case was now taken up by the DRAP for investigation. The complainant was called by the CEO to provide evidence and through Quality Assurance Division and Registration Division, the evaluation of the case was undertaken. An on-site inspection was carried out at the PINSTECH by the area Federal Inspector of Drugs. Accordingly, the report was submitted by the Inspector. According to the inspection report, the current operation is satisfactory and products are in compliance. Although the availability of required resin column is to be ensured to further improve the compliance level," Aslam added.
Regarding the issue of delay and pendency in product registration and procedure the committee was informed that registration board grants registration of a drug keeping in view safety, efficacy and quality. The committee was told that at present, there were about 3000 registration applications pending for grant of registrations (Out of 3712 applications uploaded on DRAP's website) and about 4400 applications from second list which is still to be uploaded on the DRAP's website. "These applications are being disposed of on first in, first out basis. The main reason for this large number is that after devolution of Ministry of Health in 2011, Registration Board became dysfunctional whereas the pharmaceutical manufacturers continued to submit registration applications in the meantime. However, DRAP grants registration of drugs on priority basis to new license holders and for those who add new sections in their existing manufacturing areas to be taken care for investment appreciation. In this segment, there is no pendency and all submitted applications have been disposed off. In the last three years, about 5000 registration applications of new licenses/ additional sections and pending routine applications have been evaluated and considered by the board," the committee was told.
After establishment of DRAP in November 2012, process of evaluation was improved to ensure availability of safe, efficacious and quality drugs to the public. At present, there is dearth of technical personnel in the organisation to evaluate safety, efficacy and quality parameters of a drug due to which it is becoming difficult to dispose off such large number of pending applications. However, recruitment process of new incumbents is underway and it is expected that after availability of required human resource, all pending applications shall be disposed off in speedy manner.
Replying to different questions raised by the committee members, Dr Asalm said that DRAP has adopted fast track policy for grant of export registrations and out of queue status has been granted to such applications. "Under this policy, registration board has authorised its chairman to process and approve export registration applications of me-too (generic) drugs on file. Therefore, export registration applications of me-too drugs do not need approval of registration board. However, export applications of new chemical entities/drugs require approval of Registration Board due to patient risk concerns. In the last three years, 1288 export registrations have been granted by DRAP. At present there is no pending application for export registration except when there are shortcomings in export registration application and when the safety of the products applied is not established through the reference stringent regulatory authorities of USA, EU, Canada, Japan, Australia and New Zealand, for the risk if arise to the patient that may eventually effect Pakistan's name in case of safety or quality issues in the importing country," he added.
Certificate of Pharmaceutical products (COPP) and Current Good Manufacturing Certificate (CGMP) is mandatory requirement of importing country, when a pharmaceutical company applies for registration of drugs in other countries. The importing countries require a CGMP certificate and Certificate of Pharmaceutical products (COPP), issued by exporting country's Regulatory Authority.
In order to facilitate the pharmaceutical companies for the promotion of export of their products, the Drugs Regulatory Authority of Pakistan only certifies that the manufacturer intending to export is an authorised/licensed manufacturer and the manufacturing unit is working at acceptable level of CGMP compliance. Moreover, its products are registered in Pakistan and are freely available in the market. This provides support to their application acceptance in the importing country.
In 2010, an SOP was designed for the issuance of Current Good Manufacturing Practices (CGMP) certificates and in 2013, SOP was revised and updated, According to the said SOP a panel of experts was constituted to conduct inspection of pharmaceutical units and the panel was bound to submit its report within 07 days from the date of request of the firm and Current Good Manufacturing Practices (CGMP) certificate shall be issued within 15 days to the firms on approved format contained in the said SOP.
Previously, Current Good Manufacturing Practices (CGMP) certificates were issued from the Directorate of Quality Assurance/ Laboratory Testing, DRAP, Islamabad and Certificates of Pharmaceutical products (CoPPs) were issued from the Directorate of Pharmaceutical Evaluation & Registration (PE&R), DRAP, Islamabad.
On the request of the stakeholders and in order to further facilitate the Pharmaceutical companies for the grant of such certificates the Drugs Regulatory Authority of Pakistan in its 8th meeting held on 07.10.2013 under the Chairmanship of CEO, DRAP, Islamabad had decided to de-centralised issuance of certificates to reduce the time span and is quoted as under:
"The authority decided that to facilitate the pharmaceutical industry and to expedite the procedure for export in future, certificate of Pharmaceutical products (CoPP), Free Sale Certificate and Good Manufacturing Practice (GMP) will be given. Certificate shall be issued by the respective DDG (E&M)/Officer Incharge of the field offices. However, Directorate of Pharmaceutical Evaluation and Registration and Directorate of Quality Assurance and Laboratory Testing shall provide the Standard Operating Procedure (SOPs) for both CoPP and GMP to the DDG/ Officer Incharge. Moreover, only the DOG (E&M)/Officer Incharge shall be authorised to sign CoPP, Free Sale Certificate and GMP Certificate. The 'Directorate of Pharmaceutical Evaluation shall issue the necessary direction along with the SOPs to the DDGs/Officer Incharge in this respect."
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