ISLAMABAD:
The government has approved exemption for the import of certain unregistered drugs, which will be used in hospitals and institutions.
The National Health Services, Regulation and Coordination (NHSR&C) Division apprised the cabinet in a recent meeting that the Drug Regulatory Authority of Pakistan (DRAP) was mandated to regulate the manufacturing, import, export, distribution and sale of therapeutic goods as well as enforce the Drugs Act, 1976.
The division shared that access to unapproved therapies for patients was a global phenomenon and drug regulators around the world provided special mechanisms for such access under certain conditions to ensure the availability of lifesaving drugs. It was highlighted that the World Health Organisation’s Global Benchmarking Tool for regulatory practices also included mechanisms to provide access to unapproved therapeutic products in the interest of public health.
The NHSR&C Division apprised the forum that Section 36 of the Drugs Act stipulated that the federal government may, if it is of the opinion that the public interest so requires, at any time, of its own motion or on a representation made to it, by notification in the official gazette, exempt any drug or class of drugs from the operation of any of the provisions of this Act, subject to such conditions, if any, and for such period, as may be specified in the notification.
The division said that the import of any drug that was not registered or was not in accordance with the conditions of registration was prohibited under Section 23(1)(a)(vii) of the Drugs Act. However, exemption was granted to hospitals and institutions for the import of anti-cancer drugs, cardiac drugs and any essential lifesaving drugs, as considered by the licensing authority, under certain conditions prescribed in SRO 134(1)/2021 dated February 24, 2021.
The exemption was given to provide access to innovative therapies that were yet to be registered under the Drugs Act. The five-year exemption expired on January 21, 2025. The NHSR&C Division told the cabinet that DRAP, in its 198th meeting held on January 27, 2025, recommended a five-year extension in the exemption period, starting from January 22, 2025, for anti-cancer drugs, cardiac drugs and any essential lifesaving drugs, as considered by the licensing authority.
These drugs were to be imported for use in hospitals and institutions under Section 23(1)(a)(ii) of the Drugs Act, subject to following conditions:
Imports shall be made with prior approval of the licensing authority under Rule 9 of the Drugs (Import and Export) Rules, 1976.
The drug shall not be sold or distributed in the market. It shall be on free sale in the country of origin except for lifesaving vaccines and anti-sera for human use only, where pre-qualification by the World Health Organisation (WHO) or approval from any regulatory authority, as defined by the registration board, is provided.
The drug shall be used for therapeutic purposes in hospitals or institutions only, and not for the purpose of clinical trials, examination, testing or analysis. A clearance certificate must be obtained from the assistant director concerned at the time of arrival of the shipment, before Customs’ clearance. Consumption or utilisation record must be maintained by the importer, under the supervision of a qualified person. The drug is not registered or available in Pakistan, provided that the condition mentioned in Serial No (c) shall not apply to medicines and vaccines used in the treatment and prevention of Covid-19.
A draft notification, vetted by the Ministry of Law and Justice, was also placed before the cabinet for consideration. During discussion, cabinet members inquired about the rationale for the proposed exemption, responding to which the NHSR&C Division explained that the import or local production of such essential lifesaving medicines was not commercially viable as the number of patients requiring those medicines was limited. Therefore, hospitals and institutions were constrained to import them.
The cabinet considered a summary titled “Exemption for Import of Certain Unregistered Drugs for Use in Hospitals and Institutions” and approved the proposals.
