(1) Section 8A of the Act. For the purpose of sub-section (2) of the person who wants to import medicine, the following details of the medicine he wants to import should be duly filled in Schedule-4C. An application for a drug import registration certificate should be submitted to the department in the following format:-
(a) Attested copy of the certificate issued by the authorized body stating that the manufacturer has followed good manufacturing practice in the production of the medicine,
(B) Product specification of manufactured drugs,

(C) Analytical method of manufactured drugs and report of tests conducted by the laboratory designated by the department,
(d) Pharmacopeial level,
(e) Sample of manufactured drug,
(f) Other details as prescribed by the department.
(1a) A person who wants to import substances such as main raw materials used in drug production, auxiliary raw materials, packaging materials, reference chemicals used for drug analysis, and attach the following documents for the registration certificate of such substances Schedule-4 c. The application should be submitted to the department in the following format:-
(a) Specifications of Raw Materials - and Materials Safety Data Sheet,
(b) analytical methods and test reports, and
(c) _ standard according to official drug collection (pharmacopoeial standard).
(2) Notwithstanding anything written in sub-rule (1), the following particulars shall be attached while making an application under sub-rule (1) for importation of Ayurvedic, homeopathic and other traditional medicines:-
(a) Details mentioned in a text or scripture,
(b) Product specification of the manufactured drug,
(c) Recommendation of concerned body in case of patent medicine,
(d) sample of manufactured drug and
(e) Other details as prescribed by the department.
(3) Application received according to sub-rule (1) and (1A): To register the drug mentioned in the application or the main raw materials, auxiliary raw materials, packaging materials, reference chemicals used for drug analysis as mentioned in the application. Schedule-4d if deemed appropriate. In the following formatAmong the drugs used in emergency, life-saving and intensive treatment, Schedule-4D1. Among the drugs mentioned in Schedule-4D2, among the drugs used in the treatment of orphan and neglected diseases. For the drugs mentioned in and for every other drug, taking the fee as per schedule-14, if the drug is imported, schedule-4e. The registration certificate of drug importation will be given in the following format.
(4) Notwithstanding anything written in sub-rules (1) and (2), the department may issue a letter of recommendation for import on the recommendation of the drug advisory committee when the following drugs are imported in the following circumstances:-
(a) In case of life-saving drugs, on the basis of the prescription of the concerned physician,
(b) In case of receipt of grants to governmental or non-governmental bodies or organizations,
(c) In case of importation by the government body according to the international speech system.