To ensure authenticity, APIs of drugs may soon get track-and-trace codes

Drugs Technical Advisory Board(DTAB) has recommended to the government to make it mandatory for companies to include codes to track-and-trace APIs to ensure authenticity of drugs manufactured in India. This move will potentially be the first step by the government to pinpoint the origin and movement of drugs manufactured here and ensure their authenticity. Active… Continue reading To ensure authenticity, APIs of drugs may soon get track-and-trace codes

Submit report on any adverse reaction to pelvic mesh, J&J told

The Indian government has written to US based pharmaceutical company Johnson & Johnson to furnish details of the number of surgical pelvic meshes it has imported into India in the last three years. The government’s move comes in the backdrop of the U.S Food and Drug Administration(FDA) banning the transvaginal pelvic mesh after women have… Continue reading Submit report on any adverse reaction to pelvic mesh, J&J told

Price controls hurting FDI in medical devices sector

According to the data released by the Department for Promotion of Industry and Internal Trade,Foreign Direct Investment (FDI) in the medical devices sector has decreased from $439 million in 2016 to $66 million in 2018. The decrease in FDI has been attributed to the implementation of price controls in the medical devices.Further,the inflows has decreased… Continue reading Price controls hurting FDI in medical devices sector

Chemists and druggists are passe;from now, all will be pharmacies

Drugs and Technical Advisory Board (DTAB) has given its approval to replace the words ‘chemist’ and ‘druggist’ with the term ‘pharmacy’.It will amend the Rule 65(15)(b) and Rule 65(15)(c) under Drugs and Cosmetics Rules so that medical shops can be called a ‘pharmacy’. Earlier,the description ‘Chemists and Druggists’ was to be displayed by those licensees… Continue reading Chemists and druggists are passe;from now, all will be pharmacies

After J&J case, govt. treads carefully

The Drugs Technical Advisory Board (DTAB) has recommended amendment to Rule 26 of the Drugs and Cosmetics Rules,1945,which deals with conditions under import licences. The proposed amendment makes it mandatory for import license holders to maintain control samples of imported drugs.In case of drugs bearing an expiry date on the label,the reference samples shall be… Continue reading After J&J case, govt. treads carefully

Drug advisory board proposes stringent norms for medical devices

Drugs Technical Advisory Board (DTAB) has recommended that the Centre should include all medical devices in the country under the Drugs and Cosmetics Act,1940 in a phased manner.Currently,the government regulates 27 notified medical devices under the law. Recommendations of DTAB to the Government are binding in nature.The Health Ministry will now be required to issue… Continue reading Drug advisory board proposes stringent norms for medical devices