HP | FKM is considered as the industry leader in respect of Drugs and Pharmaceuticals Law in Pakistan. The Team, spearheaded by Mr. Pirzada and Mr. Chaudhry provides what has become industry standard legal advice and services to the vast range of HP | FKM’s Pharmaceutical Clients, which includes manufacturers, distributors, importers innovative biotech, medical device, pharmaceutical and life sciences companies in the country. 

HP | FKM’s experience enables us to advise our clients on all aspects of Pharmaceutical Law and Regulatory matters, from advice on development, commercialization and exploitation to contentious proceedings before Courts and before Regulatory Authorities across the Country. 

HP | FKM’s clients in this field include the world’s largest innovative pharmaceutical, biotech, medical device, health technology and diagnostic companies. 

Mr. Pirzada has personally represented the Industry and its members before the Honourable Supreme Court and the High Courts of the Country, in matters pertaining to Drug Pricing, Packaging, Advertising, Healthcare Devices, challenges to policy and law and matters pertaining to regulatory overreach. 

Below is a brief summary of Pharmaceutical Matters which have been handled by HP | FKM: 

Pricing Matters 

HP | FKM has successfully represented more than fifty pharmaceutical companies before the Sindh High Court, Islamabad High Court and the Appellate Board of the DRAP in respect of matters pertaining to price fixation through annual price increase and hardship mechanism. Furthermore, HP | FKM has regularly dealt with matters pertaining to price fixation of originator brands, generic substitutes, new chemical entities, price anomaly cases, etc. 

HP | FKM challenged the Drug Pricing Policy 2015 before the Sindh High Court and in Suo Moto proceedings before the Supreme Court arising out of the aforementioned matters, wherein HP | FKM represented more than twenty pharmaceutical entities. Pursuant to the orders passed by the Supreme, various issues of the industry were resolved and Drug Pricing Policy 2018 was notified. 

Drug Courts 

HP | FKM has successfully represented various Clients before the Drug Courts in Pakistan, including Lucky Core Industries Limited (formerly ICI Pakistan Limited), the Searle Company Limited, in matters pertaining to overcharging of MRPs of certain drugs, purported illegal sale of pharmaceutical products and quality control matters, wherein HP | FKM has successfully defended its Clients and secured acquittals in respect of the same. 

Provincial Quality Control Board 

HP | FKM successfully represented the Searle Company Limited before the PQCB, Peshawar in matters pertaining to the alleged over charging of certain drugs. 

Moreover, HP | FKM has successfully represented OBS Pakistan Limited before the PQCB, Peshawar in a matter pertaining to quality of a drug. 

HP | FKM has also successfully represented Eli Lilly before the PQCB, Lahore in the matter pertaining to alleged shortage of a lifesaving drug. 

Issuance of Call up Notices by National Accountability Bureau 

HP | FKM challenged the issuance of Call Up Notices by National Accountability Bureau in respect of inquiry initiated against various importers of drugs i.e. Pharmatec Pakistan (Private) Limited, Akhai Agencies, Galaxy Pharma, Excel Health Laboratories, RG Pharma etc, wherein the Honourable High Court of Sindh at Karachi suspended the operation of the said Notices. 

Issuance of Notices by Drug Inspector 

HP | FKM challenged the issuance of Notices by a Drug Inspector, Sindh in respect of alleged substandard quality of certain batches of drugs manufactured by GSK Consumer Healthcare Pakistan Limited. The samples of the said drugs were not sent to the company by the drug inspector; however, reports of testing laboratory declared the said sample as substandard. The Sindh High Court suspended the said notices. 

Retainership Arrangements 

HP | FKM acts as retainer counsel for various leading local and multinational pharmaceutical companies. HP | FKM regularly advises the said companies on legal issues and correspondences with government entities and representatives and responds to notices issued by Drug Inspectors and officers of the Drug Regulatory Authority of Pakistan.