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 17,2024

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An Israeli airstrike on the office of Syria’s Baath party in Lebanon’s capital Beirut has killed the Lebanese resistance movement Hezbollah's Media Relations Officer, Mohammad Afif, reports say.

Lebanon's National News Agency (NNA) reported that the Israeli raid struck the Ba'ath party’s building in central Beirut district of Ras Al-Naba'a on Sunday, adding that the strike was an attempt to assassinate the leader of the resistance media front.

According to Baath Secretary-General Ali Hijazi, Afif was having a meeting in the Baath Party headquarters when Israel carried out the attack.

"Afif did not fight with weapons and did not lead a military unit in Hezbollah. Rather, he led a media unit," he said.

Reuters, Sky News, Al Jazeera and a number of Henrew-language media reported that Afif was killed in the Israeli strike.

However, Hezbollah has not yet confirmed Afif’s death or whether he was present at the site or not.

Earlier, the Lebanese Health Ministry said at least one person was killed and three others injured after an Israeli strike targeted a central district in Beirut.

Lebanon's al-Mayadeen television network reported that five people were killed in the attack.

The latest development came after Afif said Hezbollah was behind the Caesarea operation and targeting Netanyahu’s home during a speech at the Ghobeiry area in the southern suburbs of Beirut on October 22.

This was the second assassination attempt on Afif in the last two months, after he survived an attack on the Hezbollah media relations office several weeks ago.

Israel launched a ground assault and massive air campaign against Lebanon in late September after a year of exchanging fire across the Lebanese border in parallel with the Gaza war.

At least 3,287 people have been killed in Israeli strikes in Lebanon over the past year, with the vast majority in the past seven weeks. Another 14,222 have been wounded, mostly women and children.

In response to the ongoing aggression, the Lebanese resistance movement Hezbollah has been staging hundreds of retaliatory strikes against the occupied Palestinian territories and the Israeli forces trying to advance on southern Lebanese areas.

The movement has vowed to sustain its strikes until the regime ends the escalation.

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News Network
November 19,2024

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In the wake of the tragic drowning of three students at a resort near Ullal on the outskirts of Mangaluru city, the tourism department in Dakshina Kannada is set to implement comprehensive safety guidelines for properties with swimming pools or beach access. This initiative aims to ensure guest safety and prevent similar incidents in the future.

New Safety Mandates for Resorts and Homestays

Rashmi S.R., deputy director (in-charge) of the tourism department, announced, “We will instruct all homestays and resorts to enforce precautionary measures, especially those with pools or direct beach access. Properties must ensure 24/7 supervision, particularly during guest hours. This tragedy highlights the importance of having trained personnel on-site.”

Key Safety Guidelines

The district, home to around 150 homestays and 130 resorts, will see the following measures enforced:

  • Clearly displaying pool depths.
  • Installing adequate safety equipment, such as life buoys.
  • Employing trained lifeguards at all times.
  • Establishing clear pool operating hours.
  • Reviewing and implementing standard operating procedures (SOPs) for pool and beach usage.

Booming Beach Tourism Calls for Vigilance

Manohar Shetty, president of the Association for Coastal Tourism (ACT), Udupi, highlighted the growing popularity of beachside resorts, particularly during peak seasons. Properties in Udupi, often fully booked with tourists from Bengaluru, Mysuru, Kodagu, and Shivamogga, face increasing pressure to maintain safety standards.

Udupi district boasts 22 beachside commercial properties catering to this rising demand.

Shetty emphasized, “Authorities must scrutinize safety measures and carefully evaluate guidelines before issuing new resort licenses. Panchayats should rely on the Karnataka Town and Country Planning Act when handling such cases.”

Long-Term Solutions for Water Safety

Recognizing the need for a cultural shift in water safety, Shetty proposed integrating swimming lessons into school curricula. This move would not only equip students with essential skills but also encourage safe participation in water-based activities.

A Safer Tomorrow for Coastal Tourism

As the tourism sector thrives, Mangaluru’s proactive approach underscores its commitment to visitor safety. The tragic incident serves as a wake-up call, propelling the industry towards stricter regulations and better preparedness, ensuring that coastal vacations remain both enjoyable and safe.

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News Network
November 19,2024

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