Pharmaceutical company, also known as drug manufacturing company which is licensed for commercial business that is established to research, manufacture, market and distribute drugs / medicines for the healthcare system. The work of this industry is subject to a variety of strict rules and regulations as it involves human lives.
Pharmaceutical laws relate to the creation, sale, distribution, and use of pharmaceutical drugs. These laws include intellectual property rights to protect drug manufacturers’ research, safety standards to protect the public from harmful side effects, restrictions on marketing drugs to the public, and rules 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, it will be made sure that there is nothing located near the site which produces a disagreeable, or obnoxious odor or fumes or large quantities of soot, dust or smoke. For a license, by way of formulation a minimum plot size of not less than 2,000 square yards is required. The site verification normally takes about 3-4 weeks. Fee for site verification would be Rs.5,000.
A layout plan by the applicant, which comprises of the details of the flow of operations is also sent to the Board. If the Board is of the view that the layout drawn is in line with the current Manufacturing Practices then it will be approved. The guidelines to this affect are given in Schedule B-1 of Drug Rules 1976. Once the layout plan is found in order, it takes about 3-4 weeks for its approval. Fees for the approval of the layout plan per section is Rs. 1,000 whereas fee for revision / expansion of layout plan per section is Rs.500.
APPLICATION FOR DRUG MANUFACTURING LICENSE
As soon as the facilities are complete a formal application for grant of a Drug Manufacturing License is made on a prescribed Form-I of the Drug Rules, along with the requisite fee, for evaluation of the production and quality control facilities.
These are the four (4) types of Licenses that normally applied for to manufacture drugs:
- License to manufacture by way of basic manufacture;
- License to manufacture by way of semi-basic manufacture;
- License to manufacture by way of formulation; and
- License to manufacture by way of repacking.
A pharmaceutical unit can apply for more than one of the above licenses. An application will be made to the Secretary of Central Licensing Board in accordance to Rule 3 of Drugs Rules 1976. If the application is accepted a license will be issued for a period of five (5) years at a time, after which it is renewable on an application. Once an application for renewal has been made in time, the license continues to be in force till the decision on the application. A license may be suspended or cancelled or renewal denied if the licensee fails to comply with the conditions of license.
The Conditions for grant or renewal of a license to manufacture drugs by way of basic or semi basic manufacture are provided in Rule No. 15 of Drug Rules, license to manufacture drugs by way of formulation are provided in Rule No. 16 of Drug Rules and license to manufacture drugs by way of repacking are stated in Rule No. 18 of Drug Rules.
FEES FOR THE GRANT OF LICENSE (SCHEDULE F) OF DRUG RULES:
- By way of basic: Rs.10,000
- By way of semi-basic: Rs.10,000
- By way of formulation: Rs.35,000
- By way of repacking: Rs.20,000
REGISTRATION OF DRUGS
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.
GRANT OF DRUG MANUFACTURING LICENSE FOR EXPERIMENTAL PURPOSE
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.
DRUG REGISTRATION FEE [SEE RULE 26 (3)]
- New Drug Molecule: Rs.15,000
- Any other drug for import: Rs.15,000
- Any other drug for local manufacture including Galenical: Rs.8,000
- The Drugs Act, 1976, regulates the Pharmaceutical Sector in Pakistan
- Drug Regulatory Authority of Pakistan Act, 2012
- Drugs (Licensing, Registering & Advertising) Rules, 1976