Strides Pharma Science gets EIR for Bangalore facility

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Drug firm Strides Pharma Scienceon Wednesday said it has received the Establishment Inspection Report (EIR) from the US health regulator for its formulations facility in Bangalore. “The company’s formulations facility (KRSG Gardens) in Bangalore which was inspected by the US Food and Drug Administration (USFDA) in August 2018 and November 2018, has received the Establishment Inspection Report (EIR), thereby...

Drug pricing regime: Pharma companies express relief, health activists miffed

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The pharmaceutical industry welcomed the government order to constitute a standing committee headed by NITI Aayog to recommend the National Pharmaceutical Pricing Authority (NPPA) in regulating prices of medicines. “This would neither favour the industry nor encourage the growth of the industry nothing of that sort, but it brings balance to decision making (on price control), and not...

Drug price regulator’s wings clipped

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NEW DELHI: The Union government on Monday formed a committee housed in its think tank NITI A ayog to recommend medicines for price control, diluting the central role of the National Pharmaceuticals Pricing Authority (NPPA) in setting drug prices. Currently, NPPA functions as an autonomous body regulating prices of medicines and health products such as stents under the National List of...

Govt removes price cap on innovative drugs for first 5 years

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New Delhi: The government on Thursday exempted innovative medicines developed by foreign companies from price control for five years, giving Indian patients access to drugs that are currently only available abroad. These include orphan drugs that are used for treating rare medical conditions. Govt removes price cap on innovative drugs for first 5 years In amendments to the Drugs...

Zydus Cadila gets USFDA nod for 2 drugs

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Zydus Cadila has received final approval from the US health regulator to market Doxycycline Hyclate delayed-release tablets, used to treat bacterial infections. Zydus Cadila gets USFDA nod for 2 drugs Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market the drug in the strengths of 75 mg, 100 mg and...

Govt plans new rule to get patients compensation for defective medical devices

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The government is planning to introduce amendments to the Drugs and Cosmetics Act, 1940 which will provide compensation to patients if they are sold a faulty medical device by a manufacturer or importer. The decision has been taken in the backdrop of the uproar caused earlier this year in India and abroad over defective hip implants from US-based...

Modernising Pharma Manufacturing with co-innovation

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Envision a pharmaceutical plant where people are watchful and attentive as the business responds to change quickly and efficiently. As digital transformation ensues to disrupt, transform and reshape industries we can now picture an operation that delivers consistent production, real-time information and accurately controlled and safe processes that comply to the regulatory and demanding requirements of the pharmaceutical...

Medical device margins set to be capped at 65% in India

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New Delhi: India is set to cap trade margins on medical devices, abandoning the current price control mechanism, as it seeks to curb profiteering as well as allay concerns of device makers, particularly importers of stents and knee implants, who have complained that price caps hurt innovation, two people aware of the matter said. Prime Minister Narendra Modi is likely...

Panel finds dosing mismatches in many FDCs

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New Delhi: The expert panel which recommended a continuation of the ban on fixed dose combinations (FDCs) has found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity. Panel finds dosing mismatches in many FDCs The committee found that most pharma companies had not generated the “safety and efficacy data” of...

Dr Reddy’s gains over 1% ahead of June quarter results announcement

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Shares of Dr Reddy’s Laboratories gained over a percent on Thursday morning as investors bet on the stock ahead of Q1 results. The numbers will be declared later in the day. The stock touched an intraday high of Rs 2,118.45 and an intraday low of Rs 2,075.60. The drug maker is likely to report a four-fold jump in the first...