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 29,2020

Washington, May 29: Reiterating his offer to mediate on the border dispute between India and China, US President Donald Trump has said that he spoke with Narendra Modi about the "big conflict" and asserted that the Indian Prime Minister is not in a "good mood" over the latest flare-ups between the two countries.

Speaking with the reporters in the Oval Office of the White House on Thursday, Trump said a "big conflict" was going on between India and China.

"I like your prime minister a lot. He is a great gentleman," the president said.

"Have a big conflict …India and China. Two countries with 1.4 billion people (each). Two countries with very powerful militaries. India is not happy and probably China is not happy," he said when asked if he was worried about the border situation between India and China.

"I can tell you; I did speak to Prime Minister Modi. He is not in a good mood about what is going on with China," Trump said.

A day earlier, the president offered to mediate between India and China.

Trump on Wednesday said in a tweet that he was "ready, willing and able to mediate" between the two countries.

Responding to a question on his tweet, Trump reiterated his offer, saying if called for help, "I would do that (mediate). If they thought it would help" about "mediate or arbitrate, I would do that," he said.

India on Wednesday said it was engaged with China to peacefully resolve the border row, in a carefully crafted reaction to Trump's offer to arbitrate between the two Asian giants to settle their decades-old dispute.

"We are engaged with the Chinese side to peacefully resolve it," External Affairs Ministry Spokesperson Anurag Srivastava said, replying to a volley of questions at an online media briefing.

While the Chinese Foreign Ministry is yet to react to Trump's tweet which appears to have caught Beijing by surprise, an op-ed in the state-run Global Times said both countries did not need such a help from the US President.

"The latest dispute can be solved bilaterally by China and India. The two countries should keep alert on the US, which exploits every chance to create waves that jeopardise regional peace and order," it said.

In Beijing, Chinese Foreign Ministry spokesman Zhao Lijian said on Wednesday that both China and India have proper mechanisms and communication channels to resolve the issues through dialogue and consultations.

Trump previously offered to mediate between India and Pakistan on the Kashmir issue, a proposal which was rejected by New Delhi.

The situation in eastern Ladakh deteriorated after around 250 Chinese and Indian soldiers were engaged in a violent face-off on the evening of May 5 which spilled over to the next day before the two sides agreed to "disengage" following a meeting at the level of local commanders.

Over 100 Indian and Chinese soldiers were injured in the violence.

The incident in Pangong Tso was followed by a similar incident in north Sikkim on May 9.

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News Network
June 29,2020

New Delhi, Jun 29: Delhi Chief Minister Arvind Kejriwal on Monday paid tribute to the senior doctor of city government-run LNJP Hospital who died battling COVID-19, saying the society has "lost a very valuable fighter".

The 52-year-old doctor served in the front line of the war against the pandemic at the government facility, and died of novel coronavirus infection in an ICU of a private hospital on Sunday.

"Dr Aseem Gupta, a senior doctor of LNJP Hospital succumbed to Covid yday. He was known for going out of his way to serve his patients. We have lost a very valuable fighter. Delhi salutes his spirit and sacrifice...," Kejriwal tweeted.

The chief minister also said in his tweet that he has spoken to Dr Gupta''s wife and "offered my condolences and support".

LNJP Hospital is a dedicated COVID-19 facility under the Delhi government. It recently completed 100 days of being declared a coronavirus facility.

"LNJP Hospital has displayed great fortitude in the face of acute challenges. It''s recovery rate is going up, death rate is reducing, ICU capacity is being ramped up - the hospital is saving so many lives," the chief minister said.

A condolence meeting to pay respect to Dr Gupta has been scheduled at 1 pm in the office of the Medical Director of the hospital, a senior official said.

The doctor, a consultant anaesthesiologist died at the Max hospital, Saket in south Delhi, a private dedicated COVID-19 facility.

"He was a front line anaesthesia specialist who contracted COVID-19 infection while on duty. He tested positive on June 6, when he had mild symptoms and was shifted to a quarantine facility. His symptoms aggravated on June 7 and he was admitted in the Intensive Care Unit of the LNJP Hospital," the LNJP Hospital said in a statement on Sunday.

He was shifted to Max Hospital, Saket on June 8 on his request, it said.

The doctor was battling the disease for the last two weeks at Max Hospital, where he succumbed to the illness on Sunday, the statement said.

He was Specialist, Grade I, in the Department of Anaesthesia at the LNJP Hospital, the statement said.

Several hundreds of healthcare workers have been infected with COVID-19 till date in Delhi.

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News Network
February 10,2020

Mumbai, Feb 10: Ankita Pisudde, a resident of Hinganghat town in Wardha, was critical after sustaining 40% burns on February 3 when she was set afire, allegedly by one Vikesh Nagrale (27) while she was on her way to college.

The 25-year-old woman lecturer who was set on fire by a stalker in Maharashtra’s Wardha district last week died at a hospital in Nagpur on Monday morning, a police official said.

Ankita Pisudde, resident of Hinganghat town in Wardha, had been critical after sustaining 35 to 40% “grade III” burns on February 3 when she was set afire allegedly by one Vikesh Nagrale (27) while she was on way to her college, they said.

She was undergoing treatment at the Orange City Hospital & Research Centre here, located around 75 km from Wardha.

“Doctors at the hospital declared her dead at 6.55 a.m. today,” Hinganghat’s police inspector Satyaveer Bandiwar said.

The woman sustained deep burn injuries on scalp, face, right upper limb, left hand, upper back, neck and eyes along with severe inhalational injuries, the hospital said in a medical bulletin on Monday.

She died of “septicemic shock” after suffering from deep dermal burns along with severe inhalational injuries, respiratory distress and related complications, it said.

Around 4 a.m. on Monday, her oxygen levels deteriorated inspite of ventilator support, coupled with decreasing urine output and reduction in blood pressure, the hospital said.

As part of immediate resuscitation measures, medicines were escalated to maintain the blood pressure and all feasible steps were taken to improve the oxygen levels in blood, but the patient remained “extremely critical”, it said.

“Around 6.30 a.m., she had bradycardia and inspite of prolonged cardiopulmonary resuscitation, the patient could not be revived and was declared dead at 6.55 a.m.,” it said.

The probable cause of death was “septicemic shock”, the bulletin added.

During her treatment, she underwent tracheostomy (creating an opening in neck to place a tube into the windpipe to allow air to enter the lungs), burn dressings, debridement and escharotomies, the hospital informed.

Debridement is a medical procedure to remove dead, damaged or infected tissue, while escharotomy is a surgical procedure used to treat full-thickness (third-degree) circumferential burns.

The woman’s parents and uncle were kept informed about her deteriorating health condition and death, the hospital said, adding that the body was later handed over to police for postmortem and other formalities.

After the woman’s condition deteriorated, the hospital informed about her critical status to Maharashtra Home Minister Anil Deshmukh, Wardha Guardian Minister Sunil Kedar, Nagpur Divisional Commissioner Sanjeev Kumar, Police Commissioner Bhushan Kumar Upadhyay, Wardha Collector Vivek Bhimanwar and Wardha Superintendent of Police Basavraj Teli.

Heavy security was deployed in Hinganghat to avoid any law and order problem following her death, the police said.

Several locals, mostly women and college students, took out a march in Wardha city last Thursday, demanding death penalty for the accused.

Home Minister Deshmukh visited the hospital on Tuesday and announced that the accused’s trial would be fast-tracked.

The State government last week flew Navi Mumbai-based National Burns Centre director Sunil Keswani to Nagpur to supervise the woman’s treatment.

It has also appointed well-known lawyer Ujjwal Nikam as special public prosecutor in the case.

According to the victim’s relatives, Nagrale, who was arrested within hours of the incident on February 3, had been harassing her for quite some time.

Nagrale and the woman were friends till two years ago when she severed ties with him due to his “irrational behaviour”, the police earlier said.

A special team led by Deputy Superintendent of Police Trupti Jadhav will probe the case, the Wardha Police said last week.

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