Regulatory Changes in Pharmaceutical Industry

Pharmaceutical Related Updates Till May, 2020

 

Pharmaceutical related extensions till date:

Document Title Central / State Date Issued Valid Till
Extension of validity of registration certificate for Bioavailability and Bioequivalence study in New Drugs Central 30th April, 2020 No end date specified
Validity of consent to operate/ authorisation   for units in West Bengal extended to 30th June, 2020 West Bengal 2nd April,2020 30th June, 2020
Three months’ extension of validity of consents to operate or authorisations expired on 31.03.2020 Tamil Nadu 1st April, 2020 30th June, 2020
Three months’ extension of validity of consents to operate or authorisations expired on 31.03.2020 Odisha 31st March 30th June, 2020
Government to fast-track environmental clearance for production of bulk drugs Central 11th March, 2020 No end date specified
Andhra Pradesh PCB extends validity period of Consent to Operate and Authorization expiring on 31st March, 2020 to 30th June, 2020 Andhra Pradesh 5th April, 2020 30th June, 2020
Gujarat PCB extends term of several approvals obtained under specified waste management rules such as Plastic, Solid waste, Bio-medical. E-waste etc. whose term expire after March 1, 2020 till June 30, 2020 Gujarat 3rd April, 2020 30th June, 2020
MPCB extends the validity period of Consent to operate till July 31,2020 Maharashtra 28th April, 2020 30th September, 2020
Extension of validity of consent to establish / operate, Authorization, Registration and any other mandatory regulatory clearances under Punjab Pollution Control Board Punjab 30th March, 2020 30th June, 2020
Extension of validity of Prior Environmental Clearances till 30th June, 2020 Central 25th March, 2020 30th June, 2020

 

 

Pharmaceutical related exemption till date:

Document Title Central / State Date Issued Valid Till
Submission of notarized / apostilled documents for import and Registration of drugs in view of COVID 19 can be self-attested documents and with and undertaking to submit the notarized/apostilled documents after normalisation Central 15th April, 2020 After normalisation of situation in light of COVID 19 pandemic
DGFT lifts restriction on export of certain Active Pharmaceutical Ingredients (APIs) and formulations made from such APIs. Central 6th April, 2020 No end date specified
Amendment export policy of APIs Central 6th April, 2020 No end date specified
Appraisal of all proposals for projects or activities in respect of Active Pharmaceutical Ingredients (API) to be categorized as ‘B2’ projects under Environment Impact Assessment Notification, 2006. Central 27th March, 2020 30th September, 2020
Order by Karnataka Government exempting certain industries from the lockdown Karnataka 24th March, 2020 14th April, 2020
Ministry of Science and Technology, Department of Biotechnology, Government of India issued office memorandum dated 23rd April 2020 implenting fast track regulatory framework to deal with applications for development of vaccines and diagnostics for COVID-19 Central 23rd March, 2020 No end date specified
 Uttarakhand Govt. notifies lockdown of non-essential services like shops, commercial establishments, factories, offices etc.; effective 22nd to 31st Uttarakhand 22nd March, 2929 31st March, 2020
 Ministry of Home Affairs clarifies on industries/ activities exempted from lockdown order; specifies further exceptions to the same Central 25th March, 2020 15th April, 2020
Telangana Government permits the manufacture and supply of medical oxygen provided specified terms and conditions are followed Telangana 9th April, 2020 No end date specified
West Bengal Govt. rolls out list of additional activities over and above ones allowed in previous orders (outside containment zones) while extending the lockdown owing to Covid-19 till 17th May, 2020 West Bengal 4th May, 2020 17th May, 2020
Telangana extends lockdown till 29th May, 2020 and issues guidelines to be followed Telangana 7th May, 2020 29th May, 2020
Reiterating and in furtherance of its previous Order dated 3rd May, 2020, the Delhi Disaster Management Authority, Govt of NCT of Delhi has brought in an Order dated 8th May, 2020 Delhi 8th May, 2020 17th May, 2020

 

 

 

Pharmaceutical related new requirements till date:

Document Title Central / State Date Issued Valid Till
Ministry of Health and Family Welfare allows doorstep delivery of drugs based on the receipt of prescription physically or through e-mail amidst COVID-19 pandemic Central 26th march, 2020 No end date specified
WB Govt. order on movement of personnel and supply of essential commodities West Bengal 26th march, 2020 14th April, 2020
Haryana Government has listed down essential industries / services which are exempted from lockdown Haryana 25th March, 2020 14th April, 2020
Order by Karnataka Government exempting certain industries from the lockdown Karnataka 24th March, 2020 14th April, 2020
State and Union Territories authorised to issue orders under Essential Commodities Act, 1955 to curb inventory building / hoarding and black marketing, profiteering and speculative trading, and to take steps to ensure availability of essential commodities at fair price to public. Central 7th April, 2020 30th June, 2020
Ministry of Chemicals and Fertilizers prescribes submission of Forms by merchant importers / stockiest / manufacturers of Active Pharmaceutical Ingredients/ formulations in prescribed format Central 26th February, 2020 2nd March, 2020
APPCB – CFE & CFO for manufacturing / formulation of Hydroxychloroquine or its intermediates in bulk / formulation activity in the state of Andhra Pradesh – Instructions issued – Reg Andhra Pradesh 17th April, 2020 30th September, 2020
Operational Guidelines for essential factories/industries such as pharmaceuticals, masks, sanitizers, ventilators, COVID kits and essential food products across Andhra Pradesh Andhra Pradesh 24th March, 2020 No end date specified
NPPA fixes ceiling price for certain coronary stents and certain other specific formulations; effective from 01.04.2020 Central 25th March, 2020 No end date specified
MoHFW Amends the Drugs and Cosmetics Rules, 1945; redefines blood banks as blood centres Central 11th March, 2020 No end date specified
CDSCO rolls out a notice introducing simultaneous submission and processing of applications for Registration Certificate and Import License parallelly with New Drug application Central 26th February, 2020 No end date specified
New process for issuing Certificate of Pharmaceutical Products introduced by CDSCO to streamline the process of issuance and have a uniform procedure for review and joint inspection Central 3rd March, 2020 No end date specified
CDSCO issues updated procedures for issuance of WCC, for active substances exported to the EU for medicinal products for human use  Central 4th March, 2020 No end date specified
NPPA fixes ceiling price for certain coronary stents and certain other specific formulations; effective from 01.04.2020 Central 25th March, 2020 No end date specified
 Industries Department, Government of Kerala rolls out Standard Operating Procedures (SOPs) / conditions for all Industrial units resuming operations since 20th April, 2020 to follow Kerala 18th April, 2020 No end date specified
Puducherry Government issues guidelines on functioning of Industries Puducherry 19th April, 2020 No end date specified

 

 

 

Pharmaceutical related restrictions till date:

Document Title Central / State Date Issued Valid Till
Office Memorandum directing manufacturers/importers/ suppliers of N95 masks to maintain parity in prices Central 21st May, 2020 No end date specified
CDSCO issues list of approved COVID-19 PCR testing kit providers Central 21st May, 2020 No end date specified
CDSCO issues list of approved COVID-19 testing kit providers Central 21st May, 2020 No end date specified
Central Government vide Notification dated 4th April 2020 amends provisions of ITC(HS) Policy to the effect of prohibiting export of Diagnostic Kit Central 4th April, 2020 No end date specified
Government amends the Foreign Trade Policy, 2015-20; bans the export of Hydroxychloroquine from SEZs/ EOUs; effective immediately Central 4th April, 2020 No end date specified
Central Bureau of Narcotics directs exporters Narcotic Drugs, Psychotropic Substances and Controlled Substances to intimate the exact routing at least 48 hours prior to the shipment of a consignment containing Narcotic Drugs, Psychotropic Substances and/or Controlled Substances Central 1st April, 2020 No end date specified
The Central Bureau of Narcotics issues export authorization/import licence/ NOC via email during the lockdown due to non functioning of courier companies and speed post to facilitate trade and thereby asks firms (exporter/importer) to submit scanned copies of documents along with demand drafts. Central 1st April, 2020 No end date specified
Prohibition on sale of hand sanitisers without drug manufacturing licence label Sikkim 25th March, 2020 No end date specified
Fixation of prices of masks (2ply & 3ply), Melt Blown nonWoven Fabric and Hand Sanitizers to remain in force till 30th June, 2020 Central 25th March, 2020 30th June, 2020
Prohibition on export of all ventilators, Surgical/Disposable (2/3Ply) Masks only and Textile raw material for masks and coveralls falling under the ITC HS Codes with immediate effect i.e., wef 19th March, 2020. Central 19th March, 2020 No end date specified
Ministry of Industry and Civil supplies amends Himachal Pradesh Hoarding and Profiteering Prevention Order, 1977 Himachal Pradesh 20th April, 2020 No end date specified
CDSCO issues a list of spurious, adulterated, misbranded, or not of standard quality drugs, medical devices and cosmetics for the month of April, 2020 Central Valid for the month of April, 2020 Valid for the month of April, 2020

 

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