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New Drug-Making Standards For Indian Pharma Firms After Overseas Deaths
Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load.
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Defer Implementation Of Rules On Generic Drugs: Doctors' Body To Government
The Indian Medical Association (IMA) on Monday demanded that implementation of regulations that make it mandatory for doctors to prescribe generic drugs be deferred, raising concerns over the standard of drugs manufactured i
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India Eyes New Drugs Law After Deaths Linked To Country-Made Cough Syrups
A new drugs bill will be taken up for consideration next week on rules for importing, manufacturing and selling medicines in India, according to a parliamentary notice on Thursday.
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New Drug Export Policy Likely After Concerns On India-Made Drugs: Sources
The Union Health Ministry and the Department of Pharmaceuticals are deliberating this new policy, ministry sources said. Suggestions were sought from the Directorate General of Foreign Trade (DGFT) regarding this.
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"No Contamination Found": Tamil Nadu Official As US Flags Indian Eye Drop
Tamil Nadu's drug regulator has said it found "no contamination" in samples of eye drops manufactured by Chennai-based Global Pharma, which has hit headlines after a US watchdog linked cases of infections, blindness and even deaths to the eye drops.
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Nepal Blacklists 16 Indian Firms Including Patanjali-Linked Divya Pharmacy
Nepal's drug regulatory authority has blacklisted 16 Indian pharmaceutical companies, including Divya Pharmacy which manufactures Yoga Guru Ramdev's Patanjali products.
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"Test Solvents": Karnataka Tells Drugmakers After WHO Cough Syrup Alert
Drugs Control Department has directed drug manufacturers that certificate of analysis of glycerin and propylene glycol procured in the last one year should be submitted within seven days
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India's Zydus Cadila Seeks Nod For Its Covid Vaccine ZyCoV-D
Indian drugmaker Zydus Cadila said on Thursday it has applied to the country's drug regulator for emergency use approval of its COVID-19 vaccine and that it plans to manufacture up to 120 million doses of the shot annually.
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Hyderabad Pharma Firm Signs Agreement To Make Covid Drug 2-DG
Hyderabad-based Lee Pharma has entered into an agreement with the Indian Institute of Chemical Technology (IICT), a constituent laboratory of CSIR, to manufacture and commercialise 2-DG used to treat Covid patients, a statement said.
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On Request For Sputnik 5 Vaccine Approval, Panel Seeks More Data: Sources
The Subject Expert Committee (SEC) of the Indian drug regulator has asked pharma giant Dr Reddy's Laboratories, the Indian manufacturer of Sputnik V, the Russia-developed coronavirus vaccine, for more data regarding its application for emergency use approval for the vaccine, sources said.
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Indian Drugmaker To Pay $50 Million Fine In US For Irregularities
An Indian drug manufacturer has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration's inspection of its plant and pay USD 50 million in fines and forfeiture, the Department of Justice has announced.
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Oxford Vaccine Likely To Be First To Get Approval In India, Say Officials
With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots.
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Ready To Restart: Indian Drug Firm After UK Covid Vaccine Trials Resume
The Serum Institute of India (SII) is ready to restart coronavirus vaccine trials - pending permission from the Drug Controller General of India (DGCI) - the manufacturer said in a statement on Saturday evening
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Pharma Industry Wants Budget To Offer Tax Clarity
The Indian Drug Manufacturers Association (IDMA), a body comprising mostly home-grown pharma firms, said all excisable goods used for R&D purposes should be exempted from central excise duty.
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US Regulator's Scrutiny On Indian Drug Makers To Remain Intense: Crisil
Regulatory scrutiny of the US Food and Drug Administration (FDA) for domestic pharmaceutical facilities is expected to remain intense over the medium term, rating agency Crisil said on Wednesday.
-
New Drug-Making Standards For Indian Pharma Firms After Overseas Deaths
Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load.
-
Defer Implementation Of Rules On Generic Drugs: Doctors' Body To Government
The Indian Medical Association (IMA) on Monday demanded that implementation of regulations that make it mandatory for doctors to prescribe generic drugs be deferred, raising concerns over the standard of drugs manufactured i
-
India Eyes New Drugs Law After Deaths Linked To Country-Made Cough Syrups
A new drugs bill will be taken up for consideration next week on rules for importing, manufacturing and selling medicines in India, according to a parliamentary notice on Thursday.
-
New Drug Export Policy Likely After Concerns On India-Made Drugs: Sources
The Union Health Ministry and the Department of Pharmaceuticals are deliberating this new policy, ministry sources said. Suggestions were sought from the Directorate General of Foreign Trade (DGFT) regarding this.
-
"No Contamination Found": Tamil Nadu Official As US Flags Indian Eye Drop
Tamil Nadu's drug regulator has said it found "no contamination" in samples of eye drops manufactured by Chennai-based Global Pharma, which has hit headlines after a US watchdog linked cases of infections, blindness and even deaths to the eye drops.
-
Nepal Blacklists 16 Indian Firms Including Patanjali-Linked Divya Pharmacy
Nepal's drug regulatory authority has blacklisted 16 Indian pharmaceutical companies, including Divya Pharmacy which manufactures Yoga Guru Ramdev's Patanjali products.
-
"Test Solvents": Karnataka Tells Drugmakers After WHO Cough Syrup Alert
Drugs Control Department has directed drug manufacturers that certificate of analysis of glycerin and propylene glycol procured in the last one year should be submitted within seven days
-
India's Zydus Cadila Seeks Nod For Its Covid Vaccine ZyCoV-D
Indian drugmaker Zydus Cadila said on Thursday it has applied to the country's drug regulator for emergency use approval of its COVID-19 vaccine and that it plans to manufacture up to 120 million doses of the shot annually.
-
Hyderabad Pharma Firm Signs Agreement To Make Covid Drug 2-DG
Hyderabad-based Lee Pharma has entered into an agreement with the Indian Institute of Chemical Technology (IICT), a constituent laboratory of CSIR, to manufacture and commercialise 2-DG used to treat Covid patients, a statement said.
-
On Request For Sputnik 5 Vaccine Approval, Panel Seeks More Data: Sources
The Subject Expert Committee (SEC) of the Indian drug regulator has asked pharma giant Dr Reddy's Laboratories, the Indian manufacturer of Sputnik V, the Russia-developed coronavirus vaccine, for more data regarding its application for emergency use approval for the vaccine, sources said.
-
Indian Drugmaker To Pay $50 Million Fine In US For Irregularities
An Indian drug manufacturer has agreed to plead guilty to concealing and destroying records prior to a 2013 US Food and Drug Administration's inspection of its plant and pay USD 50 million in fines and forfeiture, the Department of Justice has announced.
-
Oxford Vaccine Likely To Be First To Get Approval In India, Say Officials
With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots.
-
Ready To Restart: Indian Drug Firm After UK Covid Vaccine Trials Resume
The Serum Institute of India (SII) is ready to restart coronavirus vaccine trials - pending permission from the Drug Controller General of India (DGCI) - the manufacturer said in a statement on Saturday evening
-
Pharma Industry Wants Budget To Offer Tax Clarity
The Indian Drug Manufacturers Association (IDMA), a body comprising mostly home-grown pharma firms, said all excisable goods used for R&D purposes should be exempted from central excise duty.
-
US Regulator's Scrutiny On Indian Drug Makers To Remain Intense: Crisil
Regulatory scrutiny of the US Food and Drug Administration (FDA) for domestic pharmaceutical facilities is expected to remain intense over the medium term, rating agency Crisil said on Wednesday.
