Govt exempts antibiotics manufactured before Feb 28 from labelling provisions of Schedule H1

New Delhi, 21 March 2014: The Union health ministry has allowed the chemists to sell antibiotics listed under the Schedule H1, but manufactured before February 28, without the new labelling requirements even as the notification regarding the antibiotics has come into effect from March 1. However, the chemists have been asked to follow other instructions for the sale of these antibiotics with regard to prescription and maintenance of sale records as per the amended rule under the Schedule H1, according to the official sources.

SCHEDULE H1 DRUG LIST AND RETAIL BILLING FORMAT

DCGI puts restrictions on use of tramadol, tapentadol and their FDCs

New Delhi, 24 Feb 2014: The Drugs Controller General of India (DCGI) has put restrictions on the formulations of tramadol, tapentadol as wells as fixed dose combinations containing tramadol, in line with the recommendations of the new rug advisory committee as these drugs had potential for respiratory depressions and addiction. Formulation of tramadol has been approved by the Central Drugs Standard Control Organisation (CDSCO) on January 27, 1993 for purpose of severe acute and chronic pain, diagnostic measures and surgical pain. Further the formulation of tapentadol had been approved on April 18, 2011 for relief of moderate to severe acute pain in adults 18 years of age or older.

Amended Narcotics Drugs Act notified after getting assent from President

New Delhi, 13 March 2014: The Narcotic Drugs and Psychotropic Substances (Amendment) Act, 2014 (NDPS), which is expected to give access to pain relief medicines including morphine to cancer patients, has been notified by the government after it got the assent from the President. According to official sources, the President gave the approval to the Act recently after the parliament passed the bill during its Winter Session in February, thus paving way for the final notification to put it into effect. The Act has been viewed as a welcome step to help the terminally ill patients get relief as it simplified the licensing for storage of morphine which would give the cancer patients access to it, for the first time since 1985 when the narcotics law was enacted.