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Medical Store or Pharmacy Registration in Pakistan

The medical industry is an important field of business not just in Pakistan, but around the world. Medicines are always in high demand here, and this line of business has great potential. In 2017, Punjab made important legal reforms to address the problem of spurious, adulterated and substandard drugs. The reforms included a new definition of substandard drugs, as well as new offences and penalties.

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Medical Store or Pharmacy Registration in Pakistan

LICENSE REQUIREMENTS FOR A MEDICAL STORE OR PHARMACY IN PAKISTAN

Before a pharmacy or medical store can be established in Pakistan, a license must be granted by the Secretary of the District Health Authority. This license will not be granted until an inspection of the premises has been conducted and an inspection report has been issued. After the inspection report has been issued, the licensing authority will issue a license for the pharmacy or medical store.

The difference between a pharmacy and a medical store is that a pharmacy must have a pharmacist present to supervise the sale of certain drugs that require a prescription. Thus, a medical store can only retain, stock, and sell such medicines which do not require a prescription. A pharmacy or medical store license, as the case may be, shall be issued by the licensing authority subject to the following conditions, amongst others: The premises must have a proper and adequate refrigerator facility and storage space for drugs; measures to ensure protection of drugs from direct sunlight, dust or dirt. The premises must not just be clean and tidy but drugs should be stored in hygienic condition. The pharmacy must fulfil the requirements detailed in the Drugs Laws and Rules.

The requirements for a pharmacy or medical store in terms of the size of the premises and the range of services offered must be met. However, it is important to note that the size of the premises for a pharmacy and medical store are different as specified under the law.

A person applying for registration must meet the qualification criteria set out in section 25 of the Pharmacy Act 1976. One of the key requirements is that each pharmacy must have a pharmacist available to supervise the sale of drugs.

APPLICATION AND FEE FOR PHARMACY LICENSE IN PAKISTAN

You can apply for a new or renewed license under Drug Rules 1976 from the licensing authority. To do so, you'll need to pay the appropriate fee into the following account:
For a new pharmacy license: Rs 3000
For a new medical store license: Rs 2000
For the renewal of a pharmacy license: Rs 2000
For the renewal of a medical store license: Rs 1000
Your application for a new or renewed license will be subject to the conditions set out in the Act and the rules.
If you want to sell, store, exhibit, or distribute drugs at more than one place, you need a separate license for each place. But if you're just storing drugs in a warehouse for storage while meeting the storage conditions, you don't need to separately register the warehouse.

FAQs

To register a medical store or pharmacy in Pakistan, you must apply through the provincial Health Department’s Drug Regulatory Authority. The process involves submitting an application form along with required documents (like proof of premises, pharmacist qualification certificates, and CNIC). Once reviewed and approved, you’ll receive a license to operate as a medical store or pharmacy.

Key documents for medical store registration include:
CNIC copies of the applicant
Proof of premises (rent agreement or ownership documents)
Qualification certificates of a licensed pharmacist
No Objection Certificate (NOC) from local authorities if needed
Affidavit declaring compliance with regulations These documents are submitted with the application form to the provincial Health Department.

Yes, hiring a licensed pharmacist is mandatory to operate a pharmacy in Pakistan. The law requires a qualified pharmacist to oversee drug dispensing, ensuring the safe handling and distribution of medicines. Pharmacists must hold a valid pharmacy license and be registered with the Pakistan Pharmacy Council.

The registration fee varies by province but is generally around PKR 5,000 to PKR 10,000 for initial licensing. Additional costs may include pharmacist hiring, premises setup, and obtaining necessary equipment. Renewal fees apply annually to keep the license active.

The time frame for obtaining a pharmacy license usually ranges from 1 to 3 months. This depends on the completeness of submitted documents, the review process by the provincial Health Department, and any inspections required. Ensuring all documents are in order can help expedite the process.

A medical store should be located in a suitable commercial area with adequate space to store medicines properly. It should also meet safety and sanitary standards, including temperature control, cleanliness, and security. Provinces may have specific regulations regarding the minimum area and distance from other pharmacies.

Yes, certain medications in Pakistan are classified as prescription-only drugs, which can only be dispensed with a doctor’s prescription. These include controlled substances and antibiotics. Over-the- counter (OTC) medications can be sold without a prescription, but pharmacists must ensure compliance with all drug regulations.

Yes, transferring a pharmacy license is possible, but it requires approval from the Health Department. The new owner must meet all regulatory requirements, including employing a licensed pharmacist and submitting a formal application for the transfer.

Provincial Health Departments conduct regular inspections to ensure pharmacies comply with regulations, such as proper drug storage, accurate record-keeping, and appropriate pharmacist supervision. Inspections are typically unannounced and occur annually or as needed to maintain licensing standards.

Pharmacy licenses are generally renewed annually. The renewal process requires the submission of updated documents and payment of a renewal fee. Failure to renew on time can result in fines or suspension of the license.

A pharmacist must have a Doctor of Pharmacy (Pharm.D) degree from an accredited institution and be registered with the Pakistan Pharmacy Council. This certification allows them to practice in licensed pharmacies and medical stores in Pakistan.

While you can own a pharmacy without a pharmacy degree, you must employ a licensed pharmacist to operate the store. The pharmacist is responsible for overseeing drug dispensing, ensuring compliance with regulations, and managing any health-related queries from customers.



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