Posts In: Pharmaceuticals

CDSCO directs applicants to upload applications through SUGAM Portal as per the New Drugs and Clinical Trial Rules, 2019

April 13, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization, 2019 has released a circular dated 10th April, 2019, with regard to uploading of applications through SUGAM Portal in...

Continue Reading

Ministry of Health and Family Welfare has added ‘organ preservative solution’ as a drug under Drugs and Cosmetics Act, 1940

April 4, 2019 OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare, in a recent notification dated 2nd April, 2019 has added “Organ preservative solution” as a drug for external or internal use...

Continue Reading

Ministry of Health and Family Welfare notifies New Drugs and Clinical Trials Rules, 2019; effective 19th March, 2019

March 28, 2019 Pharmaceuticals 0

This is a quick update to let you all know that the Ministry of Health and Family Welfare, has notified the New Drugs and Clinical Trials...

Continue Reading

Department of Biotechnology proposes the first ever ‘Guidelines for Evaluating Nanopharmaceuticals’; it is expected to ensure quality / safety / efficacy of use nanotechnology in the pharmaceuticals industry

March 25, 2019 OPS, Pharmaceuticals, states 0

Department of Biotechnology, Government of India and Indian Society of Nanomedicine have jointly prepared the Guidelines for Evaluation of Nanopharmaceuticals in India. This is to...

Continue Reading

Amendments likely to the Drugs and Cosmetics Rules; Labelling requirements to change in Form on ‘Conditions for Grant of Approval ’ and ‘Permission to import Finished Formulation & manufacture of new drug’

March 20, 2019 OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare has on 6th March, 2019 proposed changes in Drugs and Cosmetics Rules, 1945 which will impact Form 45 and 46 of...

Continue Reading

CDSCO has listed Drugs, Medical Devices and Cosmetics declared as not of standard /quality /spurious/ adulterated /misbranded for February, 2019

March 15, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization (“CDSCO”) has recently released, on their website, a list of drugs, medical devices and cosmetics declared as not of standard /quality...

Continue Reading

Haryana Government rolls Haryana Pharmaceutical Policy-2019; aims to build a robust infrastructure, give financial assistance & have simplified regulatory regime for both existing and new units

March 15, 2019 Haryana, OPS, Pharmaceuticals 0

The Department of Industries & Commerce, Government of Haryana has on 6th March, notified the Haryana Pharmaceutical Policy-2019 (“Policy”). The Policy will be valid for 5 years or till...

Continue Reading

MOHFW proposes amendments to Medical Device Rule/s; Loan Licence to Manufacture for Sale/Distribution of Class C/D Medical Devices will be given by the Central Licensing Authority

March 13, 2019 OPS, Pharmaceuticals, states 0

Ministry of Health and Family Welfare (“Ministry”) has proposed to amend Form MD-10, in Appendix of the Medical Devices Rules, 2017 (“Rules”) and released the draft...

Continue Reading

Directorate General of Health Services lists down FDCs which are rational and safe; defines process of regularisation of such rational FDCs by 31st May, 2019

March 6, 2019 OPS, Pharmaceuticals, states 0

The Central Government had previously issued various notifications prohibiting the manufacture for sale, sale and distribution of 294 Fixed Dose Combinations (“FDCs”) with immediate effect while those FDCs...

Continue Reading

Department of Pharmaceuticals clarifies that formulations mentioned in the order giving preference to local suppliers of Pharmaceutical Formulations refer to formulations mentioned under the Drugs (Prices Control) Order, 2013

March 4, 2019 OPS, Pharmaceuticals, states 0

The Department of Pharmaceuticals (“Department”) had, previously in an Order announced that purchase preference must be provided by all Government Procuring Entities to local suppliers of Pharmaceutical...

Continue Reading