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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