Drugs Registration Procedure in Sir Lanka

Imported Drugs:

Approval of the manufacturer

The first step of registering drugs from a new manufacturer (whose drugs are not registered with the DRA previously) is to submit the company information by the Authorised Local Importer representing the manufacturer. If the company profile is found to be satisfactory, registration applications will be accepted by CDDA.
Steps involved

• Submission of information about the company


• Receiving of company profile by  a Pharmacist (1)


• Assigning a serial number to the application.


• Issuing of a letter to the applicant indicating the serial number.


• Evaluation of company profile in the order of the serial number by a Pharmacist.


• Check the evaluation report by Chief Pharmacist.


• Submission of report to Director for a decision.


• Communication of decision to applicant (Approval / rejection / require more information.

Registration of drugs

The authorised local importer representing the manufacturer of a respective drug has to submit an application with drug samples to the Cosmetics Devices and Drugs Authority (CDDA) for the registration of the drug. This application should be according to the format given in the Schedule IV, Form A of CDD Regulations (See the specimen  given under the application form). A sample license should be obtained from the CDDA in order to facilitate customs clearance when importing these into the country and license fee is Rs. 2000/= at present.

Once the registration dossier is handed over to the CDDA, it will be entered in a register allocating a serial number to the application. An acknowledgement letter is issued to the importer with the serial number which will be the reference number for the application. Importer should pay processing fee for each application.

The Processing fees at present are:

1. New Chemical Entities for Sri Lanka (NCE) - Rs. 50,000/= VAT


2. New Dosage form application for Sri Lanka (NDF) - Rs.25,000 /= VAT


3. New fixed dose combination products (NFDCs) - Rs.50,000 /= VAT


4. New product of existing drugs - Rs.10,000 /= VAT


5. Re-registration application - Rs.10,000 /= VAT

All applications (except new chemical entities) will have to go through the pharmaceutical evaluation first.
New chemical entities first go to the Drug Evaluation Sub Committee (DESC) of the CDDA. Then the dossiers subjected to a pharmacological evaluation. If the committee decides that it should be registered in this country, then it is taken for thorough pharmaceutical evaluation.

Pharmaceutical quality of products is assessed through pharmaceutical data evaluated and information on factors determining quality (starting materials/ formulation, manufacturing process, intermediate & finished product controls, packaging, stability, bioequivalence data) are carefully considered.

If the pharmaceutical evaluation of the application is satisfactory, it will be submitted to the DESC. The DESC comprises consultants from various specialties and a decision is taken at the DESC meeting accordingly. If registration is recommended, DESC decides on the Schedule under which it should be registered (i.e. I, IIA, 11B, or 111). The local agent will be informed of the decision (whether rejected or approved).

If it is approved, the Certificate of Registration will be issued by the Director Medical Technology and Supplies who is the Chairman of the DESC.  Rejections will be informed giving reasons for the decision. Registration is usually valid for 5 years. The registration fee is Rs. 25000/= VAT for a product. Under special circumstances (e.g. when the drug is a new chemical entity, the manufacturer is new to this country) a provisional registration will be issued for one year and the fee is Rs. 10,000/= per year.

Every importer should employ a registered pharmacist and should posses a whole sale license from CDDRA in order to carry out the business. The license fee is Rs. 6000/= VAT per annum. He should also get separate import license on annual basis for each product from the CDDA (license fee is Rs. 2000/= VAT) for importation.

Steps involved

• Import of registration samples
  
  
  
  
  • Submission of application to import registration samples.
  
  
  • Payment of sample import licence fee to the cashier of the Ministry of Health.
  
  
  • Produce receipt at the CDDA.
  
  
  • Issue the licence indicating the quantity permitted.
  
  
  
  

• Submission of registration application
  
  
  
  
  • Submission of registration application and samples to the CDDA.
  
  
  • Check for completeness by a Pharmacist.
  
  
  • If the application is incomplete, return the application with a letter indicating deficiencies.
  
  
  • Issue letter for payment of processing fee provided the application is complete.
  
  
  • Produce payment receipt to CDDA after paying the processing fee.
  
  
  • Official acceptance of application by a Pharmacist.
  
  
  • Assigning of serial number to the application
  
  
  • Issuing acknowledgement letter to applicant indicating serial number and date of submission
  
  

• Evaluation process
  
  


• Applications are evaluated according to Serial Numbers except under special circumstances.


• Priority is given for Re-registrations and Locally manufactured products (keeping to the order of serial numbers).


• Applications for New Chemical Entities (NCE) are submitted to the Drug Evaluation Sub-committee at the monthly meeting.


• At the DESC meeting NCE applications are referred to Consultants for evaluation (mainly Efficacy & Safety).


• Evaluation reports are discussed at the DESC and a decision is taken by the DESC as to whether the NCE is acceptable to Sri Lanka.


• If more information is required that is also informed to the company.


• Samples are sent to NCL for quality testing


• All generic and branded generics are evaluated according to serial numbers


• Recommendation for final decision is given by the DESC.


• Decision of the DESC is communicated to the applicant


• After approval a Certificate of Registration will be issued on payment of the prescribed fee

Figure 1: Registration of Generic Applications

Figure2: Registration of NCEs, NDF & NFDCs

Figure 3: Registration of Vaccines