In the medical practice in India, the new drugs which are not registered in the country are required exclusively for the treatment of patients to save their lives. In such cases, any person / Hospital based on doctor’s prescription can import new drugs under personal License (11A/ 11B) issued under Drugs and Cosmetics Act, 1940 and Rules 1945.
To facilitate import of such drugs in small quantities for personal use, it is provided under the Drugs and Cosmetics Rules, 1945, that a permit for import of small quantities of drugs for personal use in Form 12B could be obtained from the office of the Drugs Controller General (India), FDA Bhawan, Kotla Road, New Delhi or designated Port Offices of Central Drugs Standard Control Organization.
The applicant is required to make an application in Form 12A, which could be downloaded from the website, along with the prescription of the Registered Medical Practitioner (RMP) indicating the quantity of drug required for the treatment of the patient. The prescription should indicate registration number of RMP. The permission in Form 12B is issued on priority basis within one or two days. Further the rules also permit import of small quantities of drugs for exclusive personal use of the passenger as part of his bona-fide baggage. The quantities of any single drug so important shall not exceed 100 average doses and shall be declared to the customs authorities, if so directed.
The Port offices of CDSCO from where permissions for import of small quantities of drugs for personal use could be obtained are situated at the Air ports of IGI Air Port, New Delhi, Air Cargo Complex, Chennai, International Air Cargo Complex, Mumbai, New Integrated Cargo Terminal Building, Kolkata, RGI Airport, Hyderabad, Airfreight Terminal, Bengaluru, Aircargo Complex, Ahmedabad and Port offices at Custom House, Chennai, New Custom House, Mumbai, Nava Sheva Port, Navi Mumbai, Custom House, Kolkata.