Health Ministry bans 328 fixed dose combination drugs

Agencies
September 13, 2018

New Delhi, Sept 13: The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. 

It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

'The Ministry of Health and Family Welfare has, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, prohibited the manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated September 7, 2018; it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect,'a statement by the ministry said on Wednesday.

Earlier, the Central Government had, through its notifications published on March 10, 2016 in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. 
Subsequently, the Government had prohibited five more FDCs in addition to the 344 under the same provisions.

However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court. 

In compliance with the directions given by the Supreme Court in its judgment dated December 15, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government.

The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. 

The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. 

With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. 

Fifteen FDCs out of the 344 prohibited on March 10 , 2016, which were claimed to be manufactured prior to September 21, 1988, have been kept out of the purview of current notifications.

Earlier, an Expert Committee appointed by the Central Government had also examined these FDCs and made recommendations in line with those of the Board as indicated above.

The Central Government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of these 328 FDCs in the country.

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News Network
November 22,2024

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Bengaluru, Nov 22: For the second day running, the Karnataka BJP on Friday staged a statewide protest condemning the government’s alleged move to notify land of farmers as Waqf property.

The BJP staged a protest before the offices of Deputy Commissioners at district headquarters.

The BJP leaders are vehemently demanding that the state government cancel a 1974 Gazette notification in this regard.

The agitators are also demanding scrapping of the Waqf Board and the resignation of Chief Minister Siddaramaiah and Minister for Waqf and Housing Zameer Ahmad Khan.

The BJP MLAs, MLCs, MPs gathered in the premises of Freedom Park and staged a protest under the leadership of Leader of Opposition R. Ashoka and slammed the state government.

MLA T.S. Srivatsa led the protest in Mysuru and hundreds of party workers and farmers staged the protest under the leadership of former MP Pratap Simha in Kodagu.

Former MP Sumalatha Ambareesh led the agitation in Mandya.

This was the first time that Sumalatha took part in the party’s programme after the Lok Sabha elections.

State President B.Y. Vijayendra claimed, “The Congress government in Karnataka is issuing notices to farmers claiming the ownership of their lands to the Waqf Board and pushing them on the streets overnight.”

In the first week of December, three teams formed by the BJP will travel across the state and record the grievances of farmers.

“The state government is attempting to snatch away the lands belonging to temples as well,” Vijayendra alleged and added that the teams would comprise all senior leaders of the BJP.

Meanwhile, the police have taken Sri Ram Sena chief Pramod Muthalik into custody while staging a protest march to the office of Zameer Ahmad Khan in Bengaluru.

Muthalik along with Hindutva activists was planning to lay siege to Zameer’s office over the Waqf row.

The police stopped Muthalik and requested him to submit the memorandum by reaching the minister’s office in a vehicle. However, Muthalik refused to go with the police and continued his footmarch. The police took him into custody following arguments.

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News Network
November 21,2024

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Shares of Adani Group companies lost about $28 billion in market value in morning trade on Thursday after US prosecutors charged the billionaire chairman of the Indian conglomerate in an alleged bribery and fraud scheme.

Gautam Adani's flagship company Adani Enterprises tumbled 23 per cent, while Adani Ports, Adani Total Gas, Adani Green, Adani Power, Adani Wilmar and Adani Energy Solutions, ACC , Ambuja Cements and NDTV fell between 20 per cent and 90 per cent.

Adani group's 10 listed stocks had a total market capitalisation of about $141 billion at 0534 GMT, compared to $169.08 billion on Tuesday.

US authorities said Adani and seven other defendants, including his nephew Sagar Adani, agreed to pay about $265 million in bribes to Indian government officials to obtain contracts expected to yield $2 billion of profit over 20 years, and develop India's largest solar power plant project.

Adani Green in a statement on Thursday said the US Justice Department had issued a criminal indictment against board members Gautam Adani and Sagar Adani and the Securities and Exchange Commission had issued a civil complaint against them.

The US Justice Department also included Adani Green board member Vneet Jaain in the criminal indictment, it said.

Adani Green's units had decided not to proceed with the proposed US dollar denominated bond offerings due to developments, it added.

"Investors will shy away from Adani Group stocks ... and that's what this sharp selling is signifying," said Saurabh Jain, assistant vice president of retail equities research at SMC Global Securities.

"This could hurt the credibility of the group and maybe borrowing costs will rise," he said.

The indictment comes nearly two years after US shortseller Hindenburg Research alleged that Adani had improperly used tax havens and was involved in stock manipulation, allegations the conglomerate denied.

Also in early Asian trading on Thursday, Adani dollar bonds slumped, with prices down 3c-5c on bonds for Adani Ports and Special Economic Zone. The falls were the largest since the Adani Group came under a short-seller attack in February 2023.

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News Network
November 15,2024

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Union minister Amit Shah on Friday, November 15, said PM Narendra Modi will amend the Waqf Act despite opposition from leaders like Uddhav Thackeray and Sharad Pawar.

"Modi ji wants to change the Waqf Board law, but Uddhav ji, Sharad Pawar and Supriya Sule are opposing it," Shah said, addressing a rally at Umarkhed in Maharashtra's Yavatmal district.

"Uddhav ji, listen carefully, you all can protest as much as you want, but Modi ji will amend the Waqf Act," he said. Shah said there are two camps in the November 20 Maharashtra assembly polls, one of 'Pandavas' represented by the BJP-led Mahayuti and the other of 'Kauravas' represented by Maha Vikas Aghadi.

"Uddhav Thackeray claims that his Shiv Sena is the real one. Can the real Shiv Sena go against renaming Aurangabad to Sambhajinagar? Can the real Shiv Sena go against renaming Ahmednagar to Ahilyanagar? The real Shiv Sena stands with the BJP," Shah said.

"Rahul Baba used to say that his government would credit money in the accounts of the people instantly. You were unable to fulfil your promises in Himachal, Karnataka, and Telangana," he said.

Shah said the Mahayuti alliance has promised that women will get Rs 2,100 per month under the Ladki Bahin Yojana. "Kashmir is an integral part of India and no power in the world can snatch it away from us," Shah said.

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