Law Reform

• HDLC has an honor to serve our valuable clients even in the field of law reforms and represented Surgical Instruments Manufacturers Association of Pakistan (SIMAP). We have challenged the Medical Devices Rules, 2018 on their behalf and several other whereby the Hon’ble Court was pleased to grant stay order against the implementation of the new Rules.
• Also challenged the medical devise rules in Islamabad high Court and obtained orders for clients to file application for establishment licnese without obtaining a drug sales license.
• The Hon’ble Lahore High Court ordered the Punjab drugs administration not to take any coercive actions against the petitioners. Also, granted stay against the implementation of this law.
• Have been honored to be co-opted as a member of the Developing Guidelines Regarding Most Prevailing Quality Related Issues in Pharmaceuticals Committee.
• Also, co-opted as a member of the committee to draft SOPs / and proposals to resolve issues of health and OTC division.
• Was part of the law reform committee tasked with the amendment of the Medical Devices Rules, 2015 and several proposals suggested by the Firm were accepted by DRAP.
• Helped to amend the Proposed Punjab Drugs Amendment Act 2018 and successfully negotiated with the Punjab Gov to withdraw some of the most impactable clauses.
• Advised Punjab Government on behalf of PPMA on Punjab Drugs Amendment Ordinance, 2015 about the harmful impacts of the law.
• HDLC lawyers regularly appear before Drug Courts in Karachi, Lahore, Quetta, Multan and Faisalabad to defend their clients, who include manufacturers, distributors and retailers of pharmaceutical products.
• HDLC is the sole legal advisor to the Pakistan Pharmaceutical Manufacturers Association (PPMA), advising the PPMA and its member companies on a range of issues, including quality control, trademarks, registration, patents, interpretation of drug laws, and implications of various statutory regulatory orders issued by the federal government.
• As retained counsel for individual pharmaceutical companies, HDLC advises them on a daily basis on the various legal issues they confront, for instance, challenging laboratory reports where a sample has been declared substandard, challenging show cause notices issued by the DRAP, and advising on intellectual property, HR and other matters.
• We have also been advising the manufacturers, distributors and retailers of pharmaceutical products in responding to various letters and notices issued by provincial and federal Drug Inspectors.
• HDLC has represented various pharmaceutical companies before the DRAP in cases and inquires pertaining to the quality of their products, and regularly represents its clients before the DRAP’s Registration Board, Licensing Board and Appellate Board.
• We successfully challenged the technical evaluation criteria in bidding documents regarding procurement of medicines for public hospitals and institutions during financial year 2016-2017.
• We have successfully challenged various statutes, ordinances and policies in the pharmaceutical realm, including the;
• Alternative Medicines and Health Product (Enlistment) Rules 2014.
• Import of Drugs Policy 2013, promulgated by the DRAP, before the Sindh High Court on behalf of the Pakistan Chemists and Druggists Association (PCDA).

Our extensive roster of constitutional petitions includes petitions:

• On behalf of several alternative medicine manufacturers against the actions of federal and provincial Drug Inspectors regarding sealing of their manufacturing facilities and raw material stores.
• before the Lahore High Court, challenging on behalf of the PPMA the constitution and composition of the Provincial Quality Control Board under the Punjab Drugs Rules 2007.
• challenging the vires of the Punjab Drugs (Amendment) Ordinance, 2015 in a constitutional petition titled “Pakistan Pharmaceutical Manufacturers association and others versus Province of Punjab”. The Lahore High Court has passed interim relief in this writ petition and restrained the Government of Punjab from taking any coercive action against the pharmaceutical manufacturers without due process of law.
• On behalf of pharmaceutical companies and the PPMA challenging the ban on toll manufacturing imposed by the DRAP’s Toll Manufacturing Policy.
• on behalf of leading national and multinational pharmaceutical companies regarding the pricing of their drugs.
• HDLC provided recommendations to the DRAP regarding the formulation of the Drugs Pricing Policy 2015, on behalf of the PPMA and Pakistan Chemists and Druggists Association (PCDA).
• We have advised some of Pakistan’s leading pharmaceutical companies in inquiry proceedings initiated by the National Accountability Bureau (NAB), based on allegations of obtaining exorbitant, illegal increases in the maximum retail prices (MRPs) of several drugs, in connivance with DRAP officials.
• HDLC has been engaged by the Federal Investigation Agency (FIA) as special prosecutor in cases regarding the manufacture of spurious and unregistered drugs.

HDLC has the honor of being the sole legal advisor to the Pakistan Medical Disposables Manufacturers Association and has represented its members in the High Courts as well as before the Federal Board of Revenue (FBR) and DRAP.