Food and pharmaceutical businesses are among the most heavily regulated in Pakistan, and among the most likely to start trading before the approvals are in place — because the product is ready, the market is waiting, and licensing looks like paperwork.

It is not paperwork. Both regimes carry criminal as well as civil consequences, and both reach the individuals responsible, not only the company.

Pharmaceuticals: DRAP

The Drug Regulatory Authority of Pakistan (DRAP) administers the framework for drugs, medical devices and related products under the DRAP Act 2012 and the legislation and rules made under it.

The obligations fall into three layers.

Establishment licensing. A manufacturer requires a drug manufacturing licence for the premises and the sections applied for, and must satisfy Good Manufacturing Practice requirements. Importers, distributors and retailers have their own licensing.

Product registration. Each product requires registration in its own right, covering formulation, specifications, stability, labelling and, where applicable, bioequivalence. Registration is product-specific — a licence to manufacture is not permission to make anything you like.

Pricing. Drug pricing is regulated, and changing a price is not a commercial decision taken unilaterally.

Then continuing obligations: batch records, quality control, adverse event reporting and pharmacovigilance, recall procedures, and the restrictions on advertising medicines to the public.

Unlicensed manufacture, unregistered products, and adulterated or spurious drugs carry serious consequences including prosecution before the drug courts.

Medical devices and cosmetics have their own tiers within the framework, and businesses regularly misclassify a product — treating a device or a supplement as outside the regime when it is not. Establish the classification first, because everything else follows from it.

Food: provincial authorities

Food regulation was devolved, and in Sindh the Sindh Food Authority licenses and regulates food businesses under the applicable provincial law.

What is typically required:

  • A licence or registration for the food business — manufacturing, processing, storage, distribution, retail or catering, each with its own conditions
  • Premises and hygiene standards, and licensing of the premises themselves
  • Food handler requirements, including medical fitness
  • Labelling in the prescribed form: ingredients, allergens, net content, batch, manufacture and expiry dating, and nutritional information where required
  • Restrictions on claims and advertising, particularly health claims
  • Traceability — being able to identify what came from where and went to whom
  • Standards for imported food, alongside customs clearance. See customs disputes at Karachi port

Inspection, seizure, penalties and closure are all available to the authority, and enforcement in Sindh is active. Restaurants and food manufacturers sealed for hygiene breaches are a routine occurrence.

Inspections: how to be ready

The businesses that come through inspections well are the ones with records.

Keep: the licence and its conditions, batch and production records, quality control results, cleaning and maintenance logs, pest control records, staff medical fitness certificates, supplier documentation and traceability records, and complaint and recall logs.

An inspection finding is much easier to answer with a document than with an assurance.

If an inspection produces an adverse finding or a notice, respond in writing within the time stated, with a remediation plan and a timetable. Regulators respond considerably better to a business that presents a credible plan than to one that argues.

Recalls

Have a written recall procedure before you need it: who decides, how affected batches are identified, how customers and the authority are notified, how product is retrieved and reconciled, and who speaks publicly.

A recall handled quickly and transparently is a manageable commercial event. One handled slowly, or concealed, becomes a regulatory and reputational problem, and may become a criminal one.

Liability when something goes wrong

Three exposures run together, and businesses tend to think about only the first:

Regulatory — penalties, suspension or cancellation of licence, closure, prosecution.

Civil — claims by consumers or by trade customers for injury or loss. See medical negligence claims for how causation is approached, and e-commerce and consumer disputes for the consumer forum route.

Personal — several provisions in this area reach the persons responsible for the conduct of the business, not just the corporate entity. Directors should treat this as a board-level compliance item.

Insurance is worth reviewing specifically for product liability and recall cover, and worth reading before you need it. See when an insurance claim is rejected.

Contract manufacturing and distribution

Much of this sector operates through third parties, and the agreements should allocate responsibility explicitly: who holds the licence and the registration, who is responsible for quality and testing, who bears a recall, audit rights over the manufacturer, and what happens to stock and registrations on termination.

For foreign principals appointing a Pakistani partner, register the trade mark here in your own name before you appoint anyone. See bringing a brand into Pakistan.

How the firm can help

We advise on classification and licensing requirements for food, pharmaceutical, device and supplement businesses, support licence and product registration applications, and review labelling and advertising against the applicable rules.

We respond to inspections, notices and enforcement action, act in proceedings including before the drug courts, and advise on recalls when they arise.

We also draft the contract manufacturing, distribution and supply agreements that allocate regulatory responsibility between the parties.

If you are launching a product, contact the firm before you manufacture. If a notice or an inspection finding has arrived, telephone the chambers.