Bulk Drug Imports

The Central Board of Indirect Taxes and Customs (CBIC) has issued a standardised checklist which a Customs officers will have to follow before clearing import consignments of cosmetics, drugs and medical devices. These products require certain mandatory compliance in terms of licenses, permissions, and registration certificates, as per the provisions of the Drugs and Cosmetics Act, 1940. The checklist follows the Central Drugs Standard Control Organisation (CDSCO)'s measures to facilitate and enhance ease of doing business in these products, the CBIC circular said. These products have been grouped into seven categories -- cosmetics; Drugs in the form of API, finished formulation, import for personal use/import of small quantities of new drug by a medical institution, import for test/analysis. The checklist for medical devices import has been grouped into in vitro diagnostics kits/devices, import of medical devices and import of raw material for manufacture of such devices. "... Th

The Union Health Ministry has published a draft notification proposing amendments to the drugs rules under which imported drugs should have a minimum residual shelf life of 12 months at the time of import. The step would ensure that patients receive medicines with adequate usable shelf life and improve utilisation of pharmaceutical inventories across the supply chain. The draft amendment published for public consultation vide gazette notification on June 22 proposes to revise the existing requirement of a minimum residual shelf life of more than 60 per cent for imported drugs to a minimum residual shelf life of 12 months at the time of import. However, in view of their specialised nature and public health considerations, the existing requirement of a minimum residual shelf life of more than 60 per cent shall continue to apply to biological products and radiopharmaceuticals. The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while ...

The US plans tariffs of up to 100 per cent on imported medicines to reduce foreign dependence and boost domestic manufacturing, a move that could reshape global pharmaceutical supply chains

Health Ministry proposes listing Navi Mumbai International Airport as a notified port under drug rules, enabling air import of medicines through the facility

Under new guidelines, testing will be reduced to one sample every two years or one sample from 20 consecutive consignments, whichever comes first

Industry insiders say pharma players are taking advantage and stocking up on APIs

Experts say scheme to boost local manufacturing will take 5-7 years to show tangible results

PM will visit Himachal Pradesh on Thursday to flag off Vande Bharat Express, lay the foundation stones of Bulk Drug Park that will attract investment of around Rs 10,000 crore

The lockdown in various Chinese provinces, including Shanghai, is likely to delay shipments by two weeks to a month, said domestic players.

The government has given approval to four waitlisted firms under the Production Linked Incentive (PLI) scheme for domestic manufacturing of bulk drugs, an official statement said on Monday. The Department of Pharmaceuticals had launched the PLI scheme for promotion of domestic manufacturing of critical bulk drugs -- Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs). It envisages setting up greenfield plants in four different target segments with a total outlay of Rs 6,940 crore for the period 2020-21 to 2029-30. All the 215 applications received for the 36 products spread across the four target segments were considered and appraised and selected participants duly informed, the Ministry of Chemicals and Fertilizers said. Now, four waitlisted applicants who are otherwise eligible have been approved against slots vacated by withdrawal by companies which had earlier been granted approvals, the ministry said. The companies which have been gi

However, there is no shortage expected at the retail level anytime soon

The orders signed by US President Donald Trump would allow states to develop plans to import cheaper drugs from Canada

According to a government notification, bulk drugs accounted for 63 per cent of total pharmaceutical imports in the country in 2018-19.

Price and capacity constraints, however, would be big impediments.

The notification has been sent to the Central Pollution Control Board, Expert Appraisal Committee and pollution control boards in all states and Union territories

FY17 imports lowest in 3 years, exemption withdrawn to provide level playing field to domestic units