What does the DCO do?

The DCO is responsible for regulating medicines in the Pakistan by ensuring they work with safety, efficacy and economical values.

How does DCO regulate medicines?

Underpinning all our work lie robust and fact-based judgments to ensure that the benefits justify any risks. This is achieved through;

• authorizing before medicines are marketed, taking both their safety effectiveness and prices into account
• ensuring clinical trails meet robust standards and safeguard patient’s interests, particularly for new molecules
• inspecting the quality of medicines as manufactured and distributed,
• encouraging everyone to report suspected problems with medicines and then investigating these reports,
• investigating, and prosecuting where necessary, cases of non-compliance including advertising claims.

What does DCO control?

DCO is a drug control organization deal with drug manufacturing licensing, drug registration, pricing, advertising, quality control, import and export of drugs.

What sanctions does DCO have against companies that break the rules?

The agency prosecutes or take other necessary action against the individuals / companies that break the law, under the Drugs Act, 1976.

Why does DCO accept money from pharmaceutical industry? Isn’t this a conflict of interest?

Companies have to pay a fee for their Marketing Authorization but we don’t seek business from them. Licensing decisions are referred to the agency’s independent Registration Board.

How is DCO funded?

Drugs Control Organization is funded by the Government grants.

I’m about to go on holiday. Can I take my medicine abroad?

Yes, if it’s for your own personal use, however, you require NOC from DCO.

Which legal bases are to be noted in order to bring a medicine product into the traffic?

Legal bases are mentioned clearly in Drug Act, 1976 and rules frame their under also uploaded on website http://www.dcomoh.gov.pk/

What documents are required for registration?

Application required to be submitted on prescribed Forms. All forms can be downloaded from DCO website. The list of additional documents / supporting documents for Biological and Non-biological drugs are also uploaded on DCO website.

How much is fee for registration and other related issue?

DRUG MANUFACTURING LICENCE

S#	TYPE OF LICENCE	FEE	RENEWAL
1.	By way of basic	PKR.10,000/-	PKR.5000/-
2.	By way of semi basic	PKR.10,000/-	PKR.5000/-
3.	By way of formulation	PKR.35,000/-	PKR.17,500/-
4.	By way of Re-packing	PKR.20,000/-	PKR.10,000/-
5.	Site Inspection & Verification	PKR.1000/-
6.	Approval of Layout Plan	PKR.1000/- Section
7.	Revision or Extension of Layout Plan	PKR.500/- Section
8.	Duplicate copy of Manufacturing licence	PKR.1000/-
9.	Duplicate copy of Registration certificate	PKR.1000/-
10.	Application for conducting clinical trials	PKR.5000/-
11.	Application for appeal (Appellate Board)	PKR.1000/- application
12.	Drug import licence fee (raw material)	PKR.250/-
13.	Additional application for raw material of same mfg.	PKR.125/-
14.	Duplicate copy of import licence (raw material)	PKR.125/-

 

 

 

 

 

 

 

 

 

DRUG REGISTRATION FEE

S#	TYPE OF DRUG	FEE	RENEWAL
1.	New drug molecule	PKR.15,000/-
2.	Any other drug for import	PKR.15,000/-	PKR.7500/-
3.	Any other drug for local manufacture including galenicals	PKR.8000/-	PKR.4000/-
4.	Variance of Reg. Application i.e. changes in inactive raw material, method of manufacture, testing method/quality specifications, product specifications, packing materials including change of labeling specifications etc.	PKR.1000/-

What is the fee head?

C-Non Tax Revenue

C02-Receipts from Civil Administration and other Functions

C028-Social Services

C02841-Health-Other Receipts

Whether every page of application shall be signed by applicant?

Yes

Whether international inspection is conducted for all countries?

For the firms regulated / approved by FDA, WHO EMEA, located in EU countries USA, Canada inspection is not required.

What should I do if I have a drug product that has been recalled?

If you have a recalled medical product, talk to your area Federal Inspector of Drugs / Provincial Drugs Inspector about the best course of action.

What does DCO do with defective products?

Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by Ministry of Health. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with regulations.

How can I contact the DCO?

If you want to communicate your comments, questions or suggestions to DCO, please contact at:

drugscontroller@dcomoh.gov.pk

For local section (North)                           ++92-051-9201924

For local section (South)                          ++92-051-9205773    

For import Section                                  ++92-051-9202635

For Licensing and Advertising Section        ++92-051-9202627

What documents required for source change?

• Credential attested by Pakistan embassy for new manufacturer
• GMP certificate issued by regulatory authority of country of origin.
• Free Sale Certificate by regulatory authority. If country of origin is other than existing one.
• Justification of change of source
• Required fee
• Evidence of renewal

What documents are required for change of brand?

• Required fee
• Justification
• Certificate of Pharmaceutical Product
• Evidence of renewal

What documents are required for change of formulation?

• Scientific justification with documentary evidence
• Required fee
• Official approval (for imported drug)
• Evidence of renewal

 What documents are required for transfer of registration?

• Required fee
• NOC of former agent
• Copy of sole agency agreement with new agent by principal
• Evidence of renewal

What documents are required for updated prescribing information?

• Official approval in country of origin for imported drug.
• Four set of comparative chart of existing & proposed data
• Evidence of renewal
• Clinical Justification

What documents are required for exemption in labeling requirements?

• Justification
• Required fee
• Evidence of renewal