Controlled Substances

International Control

• International Narcotic Control Board (INCB) whose board members are elected by the United Nations Economic and Social Council (ECOSOC) is the international competent authority for controlled substances. Its headquarters is in Vienna, Austria and is funded by the United Nations.
• The INCB monitors international trade of controlled substance and relevant controls of individual countries, while ensuring adequate supplies for medical and scientific use.
• The single convention on narcotic drugs of 1961 1961 Convention of United Nations, which was expanded and strengthened by the 1972 protocol consolidated all previous conventions and streamlined the international drug control machinery.
• Control is exercised over 120 narcotic drugs, mainly natural products, such as opium and its derivatives, morphine, codeine and heroin, but also synthetic drugs, such as methadone and pethidine, as well as cannabis and coca leaf.
• Parties to the 1961 Convention undertake to limit the production, manufacture, export, import, distribution and stocks of, trade in and use and possession of the controlled drugs so that they are used exclusively for medical and scientific purposes.
• The production and distribution of controlled substances must be licensed and supervised, and Governments must provide estimates and statistical returns to the INCB on the forms supplied for that purpose, on the quantities of drugs required, manufactured and utilized and the quantities seized by police and customs officers.
• The system of estimates covers all States, regardless of whether or not they are parties to the 1961 Convention. Each year, INCB publishes in a technical publication information about the licit movement of the internationally controlled narcotic drugs.

National Control

• Medicines that come under the category of narcotics are classified under schedule III of the Cosmetics, Devices and Drugs Act No. 27 of 1980.
• Oral morphine (i.e. tablets) which comes under schedule IIB is an exemption. Oral morphine is a valuable medication in palliative care and controls are relaxed for the convenience of cancer patients.
• Generally, importation of narcotics to Sri Lanka is allowed only through Medical Supplies Division (MSD) of the Ministry of Health. MSD which functions as the central procuring agent supplies narcotic to both government health institutions and private hospitals.

Importation of Narcotic to Sri Lanka

• An import authorization should be obtained from NMRA for each consignment intended to be imported to Sri Lanka. Importer should submit the following documents to NMRA for that purpose.
  • Letter of request.
  • Copy of the invoice / indent.
• Every importer should inform NMRA the actual quantity of narcotics imported to Sri Lanka after receiving the relevant consignment.

Obtaining narcotic drugs for the private sector

• For approval of monthly quota of narcotics required by a private hospital, an application should be furnished to NMRA. The following documents should be accompanied with.
  • Letter of request.
  • Recommendation of the authorized officers for the monthly quota, after inspection of the institution.
  • Copy of registration certificate of the institution issued by the Private Health Regulatory Council.
• They can then obtain their approved quota of narcotic drugs from the MSD, after making relevant payments. If a necessity arises, the quota approved to private hospitals can be increased by the NMRA after a re-inspection. For this purpose, a request should be made by the relevant private hospital with justifications.

The person authorized to handle narcotic drugs

• NMRA also approves the person authorized to handle narcotics in the relevant private hospital, who should be either a medical officer or a pharmacist
• Since the authorized person is required to be the safe custodian of the narcotics with the hospital, it would be more appropriate that a pharmacist assume this role.
• For approval of the authorized person, following documents should be submitted to NMRA.
  • Request letter certifying the specimen signature of the authorized person.
  • Copy of his or her registration certificate issued by the Sri Lanka Medical Council.
  • Copy of his or her national identity card.

List the Narcotic Drugs registered in Sri Lanka with the annual quota approved by the INCB for Sri Lanka as at April, 2017