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A pharmaceutical company, also known as a drug manufacturing company, is a licensed commercial entity established to research, manufacture, market, and distribute drugs and medicines for the healthcare system. The operations of this industry are subject to strict regulations due to its direct impact on human lives.
Pharmaceutical laws govern the creation, sale, distribution, and use of pharmaceutical drugs. These laws cover intellectual property rights to protect drug manufacturers' research, safety standards to prevent harmful side effects, restrictions on marketing drugs to the public, and regulations regarding how drugs may be prescribed and distributed.
In Pakistan 80% of the domestic need of medicine is fulfilled from local manufacturing whereas the other 20% through imports. If anybody wishes to establish a pharmaceutical unit, he / she needs to provide a copy of the National Identity Card, deed / lease document of the land / plot, information about the company / firm, its directors or partners and the sketch of the proposed site.
The proposed site will be verified to ensure that there are no nearby sources of disagreeable or obnoxious odors, fumes, or large quantities of soot, dust, or smoke. A minimum plot size of at least 2,000 square yards is required for obtaining a license for formulation. The site verification typically takes about 3-4 weeks, with a fee of Rs. 5,000.
The applicant must submit a layout plan detailing the flow of operations. The layout will be reviewed by the Board to ensure it aligns with current manufacturing practices, as outlined in Schedule B-1 of the Drug Rules 1976. Once the layout plan is approved, it generally takes 3-4 weeks for final approval.
Once the facilities are complete, a formal application for a Drug Manufacturing License is submitted using Form-I of the Drug Rules. The application includes the requisite fee and an evaluation of the production and quality control facilities. The following are the four types of licenses typically applied for to manufacture drugs:
A pharmaceutical unit may apply for more than one of these licenses. The application is submitted to the Secretary of the Central Licensing Board as per Rule 3 of the Drugs Rules 1976. If accepted, the license will be issued for five years, after which it can be renewed. If an application for renewal is made on time, the license remains valid until a decision is made. A license can be suspended, canceled, or renewal denied if the conditions of the license are not met.
Registration of a drug is granted by the Registration Board, set up by the Federal Government under the Drugs Act, 1976. The Board will most importantly make sure that the drug is safe to use. An application for registration of a drug to be manufactured locally is made in a prescribed Form-5 under the Drugs (Licensing, Registering and Advertising) Rules, 1976. An application for registration of a drug to be imported is made in a prescribed Form-5 (A) of Drug Rules 1976. The process for branded generic drugs takes 3-6 months 6-12 months in respect of new molecules. Once the application is complete and has been evaluated it is placed before the Registration Board for its orders. Please note that for every strength of a drug a separate application is required. A registration is issued for a period of five years at a time, after which it is renewable on an application.
According to Rule No.21 of Drug Rules 1976, if a person or an entity intends to manufacture a drug merely for experimental purposes and they do not hold a License to manufacture drugs, they must send an application in Form- 3 (Drugs Rules 1976) to the Secretary of Central Licensing Board. The License for the manufacture of drugs for experimental purposes will be granted in Form-4 of Drug Rules.