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The central government has prohibited as many as 156 <keyword id="22893276" type="General" weightage="20" keywordseo="combination-drugs" source="keywords">combination drugs</keyword> that are often administered as painkillers, multivitamins, and antibiotics, for fever and cold, among others. In a gazette notification dated August 21, the government said that the use of the drug Fixed Dose Combination of Amylase, Protease, Glucoamylase, Pectinase, Alpha Galactosidase, Lactase, Beta-Gluconase, Cellulase, Lipase, Bromelain, Xylanase, Hemicellulase, Malt diastase, Invertase, Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available. Upon recommendations of the <keyword id="20092000" type="General" weightage="20" keywordseo="Drugs-Technical-Advisory-Board" source="keywords">Drugs Technical Advisory Board</keyword>, the central government, in the greater interest of the public, has prohibited the manufacture for sale, sale, and distribution for human use of those drugs across the country with immediate effect. The move from the government comes after the matter was examined by an expert committee appointed by the central government, and the said expert committee considered the administration of this Fixed Dose Combination as "irrational". The Drugs Technical Advisory Board also examined the said FDC and recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable," the notification read. The list of banned drugs also includes drugs used for hair treatments, antiparasitic, skincare, anti-allergic. The medicines combined in more than one drug in a single pill are Fixed dose combination drugs FDC, these drugs are also known as cocktail drugs. The Indian Pharmaceutical Alliance supports the decision of the government. Sudarshan Jain, Secretary General, IPA told that, "this has been going for many years and there was a committee which reviewed the whole thing... This is a right step in the interest of patients and all aspects have been taken into consideration." "They have given the opportunity to give the data to support their products, so the right products will continue and when there is no data to support then companies have to withdraw it," Jain added. SEE ALSO: <a href="https://www.businessinsider.in/business/auto/webstories/2024-tvs-jupiter-vs-honda-activa-6g-which-110cc-scooter-should-you-buy/slidelist/112730069.cms">2024 TVS Jupiter vs Honda Activa 6G – which 110cc scooter should you buy?</a> <a href="https://www.businessinsider.in/tech/how-to/how-to-add-music-to-instagram-profile/articleshow/112732934.cms">You can now add music to your Instagram profile – here's how</a> <a href="https://www.businessinsider.in/business/auto/news/audi-q8-facelift-launched-in-india-with-a-1-17-crore-price-tag/slidelist/112707701.cms">Audi Q8 facelift launched in India with a ₹1.17 crore price tag</a>

India bans 156 commonly used combination drugs citing possible risks to humans

The government has waived the requirement for clinical trials of certain categories of drugs in <keyword id="19895063" type="General" weightage="20" keywordseo="India" source="keywords">India</keyword> if they are approved in the <keyword id="19899478" type="General" weightage="20" keywordseo="US" source="keywords">US</keyword>, the <keyword id="19922618" type="General" weightage="20" keywordseo="UK" source="keywords">UK</keyword>, Japan, Australia, Canada and the European Union. The waiver only covers five categories -- orphan drugs for rare diseases, gene and cellular therapy products, <keyword id="22559447" type="General" weightage="20" keywordseo="new-drugs" source="keywords">new drugs</keyword> used in pandemic situations, new drugs used for special defence purposes and new drugs having significant therapeutic advances over the current standard care. This waiver would ensure expeditious availability of the latest medicines for treating diseases like cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions in India. "As per Rule 101 of New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules," the Drugs Controller General of India (<keyword id="20559042" type="General" weightage="20" keywordseo="DGCI" source="keywords">DGCI</keyword>) said in an order issued on August 7. "In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely USA, UK, Japan, Australia, Canada and EU are hereby specified for following categories of new drugs," it said. Presently, several medicines already approved by other regulatory authorities in the US, the UK and the EU are not immediately available for Indian patients because of certain regulatory requirements under the Drugs and Cosmetics Act and rules made thereunder. These include the requirement of conducting a local clinical trial and generating safety and efficacy data before marketing authorisation in India, an official explained. However, Rule 101 of the New Drugs and Clinical Trials, 2019, allows the DCGI to specify certain countries for considering waiver of local clinical trials for approval of new drugs. "The advantages of operationalising this rule are that the latest medicines to treat diseases like cancers, rare diseases like SMA and DMA, and autoimmune conditions will become available expeditiously in India. "Presently, the delay in launching a new or novel medicine in India is anywhere between 5-20 years when compared to western markets. With the waiver of Rule 101, the scope of parallel launches of medicines in India along with the West will be opened up," the official explained. Besides, there will be a considerable reduction in the cost of various advanced medicines. Also, there will be a substantial reduction in the public procurement costs of the central and state governments under various schemes like the Central Government Health Scheme (CGHS) and Ayushman Bharat. Another advantage is that the resources which would have gone into approving the Indian clinical trials could now be utilised productively elsewhere, the official said. The costs of conducting local clinical trials will be reduced for pharmaceutical firms, therefore passing on these savings to patients. This is especially true for cases of rare diseases where firms have logistical difficulties in finding participants. The change will promote further research in these areas as there will be access to patient data in the Indian context much earlier, ultimately promoting indigenous innovation and shift from volume to value, the government's mission for the pharmaceutical industry, the official said. 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Govt waives clinical trial requirement for several drugs approved in select countries

Mumbai, The rupee appreciated 7 paise to settle at 83.30 (provisional) against the US dollar on Friday, following positive cues from equity markets and strong domestic macroeconomic data. Forex analysts said easing crude oil prices in the international markets also favoured the local currency. Global crude price retreated from the level of USD 84 to USD 80 per barrel as oil-producing countries' grouping OPEC+ agreed not to reduce output in 2024, they added. At the interbank foreign exchange, the rupee opened stronger at 83.29 against the dollar and traded between the peak of 83.25 and the lowest level of 83.36 against the American currency intra-day. It finally settled at 83.30 (provisional) against the greenback, registering a gain of 7 paise over the previous close. The rupee settled 5 paise lower at 83.37 against the dollar on Thursday. Meanwhile, the dollar index, which gauges the greenback's strength against a basket of six currencies, was trading 0.19 per cent lower at 103.30 on Friday. Global oil benchmark Brent crude futures declined 0.23 per cent to USD 80.67 per barrel. On the domestic equity market front, Sensex surged 492.75 points, or 0.74 per cent, to settle at 67,481.19 points. The Nifty advanced 134.75 points, or 0.67 per cent, to 20,267.90 points. A monthly survey on Friday said India's manufacturing sector continued with its robust performance in November. The seasonally adjusted S&amp;P Global India Manufacturing Purchasing Managers' Index (PMI) rose to 56 last month from the eight-month low of 55.5 recorded in October. Foreign institutional investors were net buyers in the capital market on Thursday as they purchased shares worth Rs 8,147.85 crore, according to exchange data. According to the government data released on Thursday, India's gross domestic product (GDP) growth of 7.6 per cent during July-September beat most estimates, including 6.5 per cent projected by the <keyword id="6354335" type="General" weightage="80" keywordseo="reserve-bank-of-india" source="Orion">Reserve Bank of India</keyword> (<keyword id="30067" type="General" weightage="80" keywordseo="rbi" source="Orion">RBI</keyword>), retaining the country's tag of the world's fastest-growing major economy. Also, another data released simultaneously showed that the output of eight key infrastructure sectors jumped 12.1 per cent in October 2023 against 0.7 per cent expansion in the year-ago period. The government's fiscal deficit at the end of October touched 45 per cent of the full-year budget estimate, as per the data released by the <keyword id="513373" type="General" weightage="80" keywordseo="controller-general-of-accounts" source="Orion">Controller General of Accounts</keyword> (CGA).

Rupee tracks buoyant equity markets, rises 7 paise to 83.3/USD

<ul><li>DCGI has approved market authorisation for the COVID-19 vaccine <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> as a heterologous booster dose for adults.</li><li>The DCGI's approval came following recommendations by the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> of the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="50" keywordseo="cdsco" source="Orion">CDSCO</keyword>).</li></ul>The <keyword id="6386816" type="General" weightage="50" keywordseo="drug-controller-general-of-india" source="Orion">Drug Controller General of India</keyword> (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of <keyword id="9617748" type="General" weightage="50" keywordseo="covishield" source="Orion">Covishield</keyword> or <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword>, official sources said on Monday. The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). Prakash Kumar Singh, Director of Government and Regulatory Affairs at the <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> (<keyword id="52604" type="General" weightage="80" keywordseo="sii" source="Orion">SII</keyword>), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said. "The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said. The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions. Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the <keyword id="43588" type="General" weightage="50" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) on December 17, 2021. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> and low-and-middle-income countries. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/amazon-great-republic-day-sale-2023-best-deals-and-offers-on-tvs/articleshow/96987966.cms">Amazon Great Republic Day Sale 2023 – Best deals and offers on TVs</a> <a href="https://www.businessinsider.in/tech/apps/news/these-audio-setting-tweaks-can-make-music-sound-better-on-spotify/articleshow/96876010.cms">These audio setting tweaks can make music sound better on Spotify</a>

You Searched For "Drugs Controller General of India" and got 4 results

India bans 156 commonly used combination drugs citing possible risks to humans

ANI

Govt waives clinical trial requirement for several drugs approved in select countries

PTI

Rupee tracks buoyant equity markets, rises 7 paise to 83.3/USD

PTI

Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

PTI

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