Islamabad: Spurious drugs: Ministry eased rules for firms
ISLAMABAD: The health ministry, in gross violation of a Supreme Court directive to control the flow of spurious medicines, removed a number of clauses of its own notification giving extraordinary relief to pharmaceutical companies, Dawn has learnt.
In April 2006, the apex court had directed the ministry to “take measures enabling every person, including consumers, to know about the activities which have been undertaken by the health department, and their future plan to control the flow of spurious medicines.”
The government notified Rule 24 of the Statutory Regulatory Order (SRO) in September 13, 2007, but the health ministry through a notification on April 17, 2008, deleted its sub-clauses – 18, 19, 20, 21, 22, 23, 24 and 25 – which put strict checks on the pharmaceutical industry.
The source said a dubious drug registration process had been adopted during the last three years due to omission of these sub-clauses. “Several national and multinational drug companies who were issued registration certificates for almost 40,000 drugs by the ministry also got advantage of the deletion,” said the source close to the developments.
One of the omitted clauses said: “The application for the registration of new molecules shall be critically evaluated to ensure the quality, safety and efficacy of applied drug. The applicant shall submit local clinical trials for post-marketing surveillance within one year of the registration to determine the safety as well as efficacy and quality.”
Even the drug registration process was based on more scientific lines. “The applicants shall submit stability studies (shelve life of drugs) along with scientific data supported with relevant figures, which shall be evaluated to ascertain quality of the applied drugs. If the innovative product is not registered it shall be imported after the experimental permission.”
According to the source, clause 18 said: “The registration board may appoint a panel of experts or inspectors to inspect the premises of a manufacture of drugs (local or foreign) at the cost of the applicants and submit its report to the board. The panel shall follow procedures approved by the federal government.”
The clause relating to expiry and spurious drugs was also deleted which stated that the registration board shall issue recall notices for withdrawal of stocks from the market if any drug was declared spurious, substandard, adulterated or misbranded by any drug testing laboratory. Likewise, the marketing authorisation holders (drug companies) shall inform the drug registration board for the recalls within 15 days after identification of the problem.
Even the powers of investigation by the federal inspectors were clipped during the revocation of several clauses of the SRO, added the source.
Clause 23 related to public interest which warns: “The registration board may, in public interest, restrict or stop the import of any drug or classes of drugs which are produced in Pakistan in sufficient quantity.”
The source said deletion of the clause had hugely helped the drug companies in marketing of their drugs in the local market.
The marketing authorisation holder (manufacturer) or his authorised agent duly holds a valid authority letter while issuing a warranty from the company for selling any drug for the purpose of distribution or retail sale.
Despite repeated attempts, Director-General Health Dr Asad Hafeez, who is also the spokesman for the health ministry, and in-charge secretary of the ministry Nargis Sethi could not be contacted for comments.
The complete article can be found at Dawn News.