Govt eases norms to import unapproved life-saving drugs

Now, patients will no longer have to face hassle and run helter-skelter for the life-saving medicines they have to import for their personal consumption.

The Union Health Ministry recently relaxed norms to facilitate speedy availability of unapproved drugs, medications which are not permitted to be imported or marketed in the country, in small quantities for personal use.

According to a senior official in the Ministry, the Drugs Technical Advisory Board (DTAB), a highest decision making of the Health Ministry on the technical issues, has amended the Drugs and Cosmetics (D&C) Rules of 1945 in the matter.

So far, the Central Drugs Standard Control Organisation has been issuing permits for import only for a period of six months. However, as per the new rule being implemented from June 1, a patient can obtain the permit and import the drug “till such time” he or she “requires the drug as per the prescription of a registered medical practitioner”. A new clause is also added to Form 12B stipulating that “the permit holder shall submit details of drugs imported and utilised to the licensing authority on a yearly basis”.

During the course of treatment, drugs which are not approved and permitted to be sold in the country are sometimes required to save a patient's life. To facilitate import of such drugs in small quantities, a permit in Form 12B could be obtained from the office of the Drugs Controller General of India under the D&C Rules, said the official.

The government has designated certain port offices of CDSCO from where permissions for import of small quantities of drugs for personal use could be obtained. These include those at airports of IGI Airport, New Delhi, Air Cargo Complex, Chennai, International Air Cargo Complex, Mumbai, New Integrated Cargo Terminal Building, Kolkata, RGI Airport, Hyderabad, Airfreight Terminal, Bengaluru and Port Offices at Custom House, Chennai, New Custom House, Mumbai, Nava Sheva among a few others.