Govt amends D&C Rules to ease regulation to import unapproved life-saving drugs in small quantities for personal use

Arun Sreenivasan, New DelhiTuesday, June 12, 2018, 08:00 Hrs  [IST]

The Union health ministry has relaxed regulations 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. The decision is expected to bring some relief for patients who are in dire need of such imported life-saving medicines.

The ministry, after consultations with the Drugs Technical Advisory Board, has amended the Drugs and Cosmetics (D&C) Rules of 1945 to this effect and the new regulation came into force on June 1.  

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.

However, the Central Drugs Standard Control Organisation has so far been issuing these permits only for a period of six months. As per the new rule, 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”.

The change in rule assumes significance as, according to healthcare experts, many life-saving drugs are currently available in India only through the so-called compassionate use clause. For instance, drug-resistant strains of tuberculosis (TB) are on the rise in the country and two new drugs showing promising results, bedaquiline and delaminid, are available only through special permission. “An application for importing the drug, stating that it is exclusively for personal use, needs to be submitted for each patient. It is a long process that leads to substantial treatment delay and could jeopardise their survival chances. The new rule is a welcome step as it allows the patient to use a permit as long as the drug is needed. Many of these medicines have to be taken for more than 48 months,” a healthcare professional associated with anti-TB campaigns opined.

Though steps to ensure patients’ access to life-saving drugs are critical, allowing unregulated foreign drugs into the market can eventually endanger patients, industry experts point out. Many imported prescription drugs are neither safe nor dependable as many foreign manufacturers produce untested counterfeit drugs and then manipulate international trade rules to hide their country of origin. The best way to help patients is to continue promoting research and medical innovation at home, they say.