Appendix 1: Morphine Licensing System under Unamended State Narcotics Rules

Following the enactment of the 1985 Narcotic Drugs and Psychotropic Substances Act, India’s states and territories adopted narcotics regulations that, among others, set out the procedure for obtaining access to opioid medications. Although these regulations vary from state to state, the procedure they provide for has many similarities across the country.

Procedure for Obtaining a Possession License

A document prepared under the Collaborative Programme of the Indian government and the World Health Organization, entitled “Guidelines for Developing of Palliative Care Services,”[174] lists the following steps as typically required for obtaining a possession and import license under the unamended regulations:

1. Application for license submitted to the local excise office
2. Inspection of applicant institution by local excise official
3. Application forwarded to the state excise commissioner
4. Application forwarded to the state drugs controller
5. Inspection of the applicant institution by the state drugs inspector
6. Transmission of approval of drugs inspector to the drugs controller
7. Application forwarded to health authority for approval
8. Health authority forwards to relevant official for inspection
9. Transmission of approval of health authority to drugs inspector
10. Transmission of approval of drugs controller to excise commissioner
11. Transmission of approval to local excise office
12. License issued

Figure 1 gives a visual overview of these various steps. Possession licenses generally have to be renewed once per year.

Figure 1: Procuring Oral Morphine in a State without Amended Regulations [175]

Procedure for Obtaining Procurement Licenses

The procedure for obtaining procurement licenses—such as import and transport licenses—is similar to that for the possession license. Again, an application needs to be lodged with the excise department, which seeks the involvement of the drugs controller and health authority. Once more, the application has to be approved at various levels of the bureaucracy at both departments. After the excise office issues the import license, the medical institution has to take the following steps before it actually receives the morphine:

1. Order is placed with manufacturer, along with payment
2. If manufacturer is in another state, it must apply for an export license from the state excise office
3. Excise office issues the export permit to the manufacturer
4. Drugs are dispatched by registered mail
5. The applicant institution receives the parcel
6. Local excise office is informed
7. Visit by excise official to open parcel in his/her presence[176]