Government News

CDSCO issue guidance documents for Approval Of BA/BE NOC for Export Purpose

  • Posted on: 13 March 2018
  • By: Shalini.Sharma

A large number of applications are being filed to the office of DCG (I) at CDSCO (HQ) by Pharmaceutical companies, both manufacturers and CRO’s on behalf of them, requesting for the approval to carry out Bioequivalence studies on Indian subjects for export purpose.

FDA announce the guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.”

  • Posted on: 6 March 2018
  • By: Shalini.Sharma

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “E18 Genomic Sampling and Management of Genomic Data.” The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation.

FSMPs harmonise with IMS Act provisions to save lives of babies with IEM

  • Posted on: 6 March 2018
  • By: Shalini.Sharma

Foods for special medical purpose (FSMPs) is a category of foods that has been harmonised with the IMS Act to save the lives of babies suffering from inborn errors of metabolism (IEM), a life-threatening medical condition affecting thousands of infants in the country.

NPPA fixed/revised ceiling prices/retail prices of 12 formulations under Drugs (Prices Control) Order, 2013

  • Posted on: 5 March 2018
  • By: Shalini.Sharma

The National Pharmaceutical Pricing Authority fixes/revises the price of the Scheduled formulation.

The scheduled formulations are: Atorvastatin + Aspirin Capsule (Atchol-ASP 150), Nifedipine + Lidocaine Cream (LOXHEAL), Pioglitazone + Gliclazide + Metformin Tablet (GLZ Total), Ibuprofen + Paracetamol Tablet (Brufen Plus), Misoprostol Tablet, Glimepiride + Metformin Tablet, Melphalan + Povidone Injection (Melphalan Injection IP 50mg), Trastuzumab Injection, Vitamin D3
(Cholecalciferol) (DRISE SURE), Furosemide Injection, Snake Venom Antiserum-Soluble/ Liquid Polyvalent Injection, and Phenobarbitone oral liquid.

NPPA fixes retail prices of 14 formulations under DPCO, 2013

  • Posted on: 3 March 2018
  • By: Shalini.Sharma

As per notification dated 23 February 2018, NPPA has fixed retail prices of 14 formulations under Drugs Prices Control Order, 2013.

Shri J P Nadda launches Viral Load test for People Living with HIV/AIDS (PLHIV)

  • Posted on: 27 February 2018
  • By: Shalini.Sharma

Shri J P Nadda, Union Minister of Health and Family Welfare launched the ‘‘Viral Load testing for all People Living with HIV/AIDS (PLHIV),”at a function.
The initiative will provide free of cost viral load testing for 12 lakh PLHIV on treatment in the country at least once a year. Shri Nadda further announced that after ‘Treat All’, Viral Load test is a big step forward in treating and monitoring people living with HIV. “This Viral Load test is of immense importance to monitor the effectiveness of treatment of patients taking lifelong Antiretroviral Therapy,” he said.
Smt. Anupriya Patel, Minister of State for Health & Family Welfare was also present at the launch function.