Draft amendments in rules framed under Drug Act 1976 (for comments within 7 days of publication of SRO).

S.R.O 1084(I)/2022 (Amendments in drugs (Appellate Board) rules 1976)

S.R.O 1085(I)/2022 (Amendments in drugs (Import and Export) rules 1976)

S.R.O 1086(I)2022 (Amendments in drugs (Federal Inspectors, Federal Drug Laboratory, Federal Government Analysts)) rules 1976

S.R.O 1087(I)/2022(Amendments in drugs (Licensing, Registering, Advertising) rules 1976)

Proposed amendments in the Rules : DRAP invites comments from stakeholders and public on the draft amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976;

The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. The proposed amendments relates to the minimum area requirement for establishment of a pharmaceutical manufacturing units and adoption of Pharmaceutical Inspection Cooperation / Scheme (PIC/S) Guidelines for Good Manufacturing Practices (GMP), in order to further align more closely with the international standards and best practices, as practiced by many other regulatory authorities around the world.

The DRAP proposes to do so primarily by incorporating the provisos to enable manufactures and regulators to follow principles set by the Pharmaceutical Inspection Cooperation / Scheme (PIC/S) to maintain the quality standards at an acceptable level. PIC/s guidelines provide comprehensive guidance for both industry and regulators on various aspects of Good Manufacturing Practices.

DRAP has the mandate to issue guidelines and to monitor enforcement of licensing of manufacture of therapeutic goods and to implement internationally recognized standards under Section 7(c)(i) & (ix) of the DRAP Act, 2012. Control of environmental conditions for pharmaceutical industry is essential to manufacture quality products. and implementation of Good Manufacturing Practices (GMP) guidelines is critical to ensure the proper design, monitoring, and control of the manufacturing processes and facilities.

Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification in the official Gazette of Pakistan using prescribed format, via email to aamar.latif@dra.gov.pk, or can be posted at mailing address, Deputy Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.

SRO 778 (I)/2022 dated 10th June, 2022

DRAP notified the Pharmacovigilance Rules, 2022, for active monitoring of safety of therapeutic goods across the country

The pharmacovigilance Rules, 2022, notified on 22nd April, 2022 , came into effect. This will provide a legal framework to monitor the safety of therapeutic goods throughout their use in the healthcare practice. This legislation details responsibilities of all stakeholders in active supervision of the product’ safety and monitoring, and provides a legal framework to implement and strengthen the pharmacovigilance system across the country. The newly approved rules will have a significant impact to improve pharmacovigilance system in the country, and provides responsibilities to be carried out by the National Pharmacovigilance Centre, Provincial or regional pharmacovigilance Centres, Public Health Programs (PHPs), and as well as, for the products’ registration holders (marketing authorization holders).

The Pharmacovigilance Rules,2022 are aimed at :-

  • Establishing the pharmacovigilance system for the collection and monitoring of Adverse Events, and related data on safety of therapeutic goods;
  • Review and assessment of safety data for effective regulatory actions to ensure the safe use of drugs, vaccines, medical devices, etc.;
  • Encourage reporting of Adverse Events by the Healthcare Professionals, Patients and Consumers of therapeutic goods;
  • Better communication and collaborative working among all stakeholders.

To know more about please navigate to “How DRAP Monitor Safety of Therapeutic Goods“, and “How to Report Adverse Events?”

Amendments in the Medical Devices Rules, 2017 (SRO 1500 (I) 2021)

S.RO.1500(I)/2021.- In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with approval of the Federal Government, is pleased to direct that the following amendments shall be made in the Medical Devices Rules, 2017, namely:-

 In the aforesaid Rules,-

(a) in rule 6, in sub-rule (l).-

(i) for clause (c), the following shall be substituted, namely;- “(c) the manufacturing shall be conducted under the active supervision of competent technical staff, who shall be in-charge of production, a whole time employee of the manufacturer and having relevant qualification and experience as deemed appropriate by the MDB;”; and

(ii) for clause (e), the following shall be substituted, namely:- “(e) the in-charge of quality control shall be a whole-time employee of the manufacturer and shall possess relevant qualification and experience as deemed appropriate by the MDB;”; and

(b) in rule 63, in sub-rule (3), expression after the words “omit any”, the words “Form or” shall be inserted.