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
May 27,2020

Washington, May 27: Most viruses and other germs do not spread easily on flights, the US Center for Disease Control and Prevention has said in its COVID-19 guidelines which do not recommend following social distancing between two passengers inside a plane or keeping the middle seat unoccupied.

As a result of coronavirus pandemic, air traffic inside the US has come to a near halt. Air traffic is said to be down to about 90 per cent. For all travellers coming from overseas, the Center for Disease Control and Prevention (CDC) has recommended 14 days quarantine.

"Most viruses and other germs do not spread easily on flights because of how air circulates and is filtered on aeroplanes," the CDC has said in its set of COVID-19 guidelines for air travellers.

However, it noted that the air travellers were not risk-free especially in the time of the coronavirus pandemic and recommended Americans to avoid travel as far as possible.

"Air travel requires spending time in security lines and airport terminals, which can bring you in close contact with other people and frequently touched surfaces," it said.

"Social distancing is difficult on crowded flights, and you may have to sit near others (within six feet), sometimes for hours. This may increase your risk for exposure to the virus that causes COVID-19," the CDC said.

But instead of recommended social distancing inside commercial planes, the CDC has advised a series of preventive and hygienic measures to be taken by the airlines pilot and crew to prevent the spread of coronavirus.

The US Department of Transportation and Federal Aviation Administration in its latest safety alerts for operators on May 11 said that air carriers and crews conducting flight operations having a nexus to the US, including both domestic and foreign air carriers, should follow CDC's occupational health and safety guidance.

The CDC issued its guidelines in first guidelines for the airlines and airline crew on March and again in May.

The CDC, which has issued an exhaustive social guideline measures in various sections, is silent on keeping the middle seat of a plane unoccupied so as to maintain the six feet distance between two passengers.

It calls for the plane crew to report to the CDC a traveller with specific COVID-19 symptoms like fever, persistent cough, difficulty in breathing and appearing unwell.

Asking the airlines and cabin crew to review infection control guidelines for cabin crew, the CDC recommends several measures for cabin crew to protect themselves and others, manage a sick traveller, clean contaminated areas, and take actions after a flight.

Prominent among them include washing hands often with soap and water for at least 20 seconds, particularly after assisting sick travellers or touching potentially contaminated body fluids or surfaces and use of alcohol-based hand sanitizer (containing at least 60 per cent alcohol) if soap and water are not available.

Airlines should consider providing alcohol-based hand sanitizer to cabin and flight crews for their personal use, it said.

The CDC guidelines do not recommend following social distancing inside a plane between two passengers or keeping the middle seat unoccupied. But it asks to minimise contact between passengers and cabin crew and the sick person.

"If possible, separate the sick person from others (by a distance of 2 meters or 6 feet, ideally) and designate one crew member to serve the sick person. Offer a facemask, if available and if the sick person can tolerate it. If a facemask is not available or cannot be tolerated, ask the sick person to cover their mouth and nose with tissues when coughing or sneezing," said the CDC guidelines.

If no symptomatic passengers were identified during or immediately after the flight, the CDC recommends airlines to follow routine operating procedures for cleaning aircraft, managing solid waste, and wearing PPE.

"If symptomatic passengers are identified during or immediately after the flight, routine cleaning procedures should be followed, and enhanced cleaning procedures should also be used," it said.

Clean porous (soft) surfaces (e.g, cloth seats, cloth seat belts) at the seat of the symptomatic passengers and within 6 feet of the symptomatic passengers in all directions, it added.

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News Network
January 29,2020

Aurangabad, Jan 29: Accusing Prime Minister Narendra Modi and Union Home Minister Amit Shah of creating a conflict between Hindu and Muslim communities in the country, former JNU student leader Kanhaiya Kumar has said the Citizenship (Amendment) Act (CAA) was adding fuel to the fire.

He was speaking at a rally held on Tuesday at Pathri in Parbhani district of Maharashtra against the CAA and the National Register of Citizens (NRC). It was organised by NCP MLC Abdullah Durrani.

"Modi and Shah used to create conflicts between Hindus and Muslims during the Gujarat elections. Now they are adopting the same strategy in the country," Kumar alleged.

Citizens should keep the religious conflicts aside and question the present government about unemployment and the poor state of the economy, he said.

"Through the CAA, the government is adding fuel to the fire, which is already raging in the country," he alleged.

When anyone questions the government about the problems existing in the country, it in turn asks him about his citizenship, the former JNUSU leader alleged.

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Agencies
June 18,2020

New Delhi, Jun 18: Vodafone Idea on Thursday told the Supreme Court that it has incurred Rs 1 lakh crore losses as it insisted it is not in a position to furnish bank guarantees.

A bench comprising Justices Arun Mishra, S. Abdul Nazeer, and M.R. Shah, taking up the adjusted gross revenue (AGR) matter through video conferencing, directed the telecom companies to submit their financial documents and books for the last 10 years.

Asking Vodafone if it was a foreign company, the bench said that how can the company say it would not furnish any bank guarantee.

"What if you fly away overnight in future without paying anything?" it asked.

Senior advocate Mukul Rohatgi, representing Vodafone Idea, denied his client is a completely foreign firm and cited before the bench its tie-ups and investments.

Vodafone owes over Rs 58,000 crore as AGR dues and so far, has paid close to Rs 7,000 crore.

Rohatgi contended before the court that the telecom company is in a tough situation, and cannot furnish any fresh bank guarantee, as profits have eluded the company in past many quarters. He submitted before the bench that Rs 15,000 crore bank guarantees are lying with the government, and his client's losses are over Rs 1 lakh crore.

"I cannot offer any more surety," he informed the bench.

Justice Mishra noted that this is public money and these dues should be recovered. "Do not tell us that you will pay if you were to make profits... the money must come," he noted.

Justice Shah observed that the telecom industry is the only industry which earned during the Covid-19 pandemic. "After all, this money will be used for public welfare", he said.

Rohatgi argued that his client would have to fold up if orders were issued to clear dues tomorrow. "11,000 employees will have to go without notice, as we cannot pay them," he added.

Senior advocate Abhishek Manu Singhvi, appearing for Bharti Airtel, contended before the court that out of Rs 21,000 crore AGR dues, the company has already deposited a sum of Rs 18,000 crore.

He argued that his client has given a bank guarantee, in excess of demand, to DoT, and supported the proposal for phased repayment of remaining AGR dues. He insisted that the company needs to sit down with the government and calculate the dues. Airtel owes Rs 25,976 crore after paying Rs 18,000 crore, as per the government.

Senior advocate Arvind Datar, representing Tata Telecom, informed the bench that his client has paid Rs 6,504 crore in AGR dues so far, and furnishing a bank guarantee may adversely impact investments in the sector.

The total AGR dues are close to Rs 1.5 lakh crore.

The top court will now take up the matter in the third week of July.

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