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 7,2020

May 7: India is projected to record the highest number of births in the 9 months since COVID-19 was declared a pandemic in March, with more than 20 million babies expected to be born in the country between March and December, according to top UN body.

The United Nations Children's Fund (UNICEF) warned that pregnant mothers and babies born during the pandemic across the world were threatened by strained health systems and disruptions in services.

An estimated 116 million babies will be born under the shadow of COVID-19 pandemic, UNICEF said on Wednesday, ahead of Mother's Day, observed on May 10.

These babies are projected to be born up to 40 weeks after COVID-19 was recognised as a pandemic on March 11.

The highest numbers of births in the 9 months since the pandemic was declared are expected to occur in India, where 20.1 million babies are projected to be born between March 11 and December 16. Other countries with the expected highest numbers of births during this period are China (13.5 million), Nigeria (6.4 million), Pakistan (5 million) and Indonesia (4 million), it said.

"Most of these countries had high neonatal mortality rates even before the pandemic and may see these levels increase with COVID-19 conditions," UNICEF said.

It is estimated that there will be 24.1 million births in India for the January-December 2020 period.

UNICEF warned that COVID-19 containment measures can disrupt life-saving health services such as childbirth care, putting millions of pregnant mothers and their babies at great risk.

Even wealthier countries are affected by this crisis. In the US, the sixth-highest country in terms of the expected number of births, over 3.3 million babies are projected to be born between March 11 and December 16.

"New mothers and newborns will be greeted by harsh realities," UNICEF said, adding they include global containment measures such as lockdowns and curfews; health centres overwhelmed with response efforts; supply and equipment shortages; and a lack of sufficient skilled birth attendants as health workers, including midwives, are redeployed to treat COVID-19 patients.

"Millions of mothers all over the world embarked on a journey of parenthood in the world as it was. They now must prepare to bring a life into the world as it has become – a world where expecting mothers are afraid to go to health centres for fear of getting infected, or missing out on emergency care due to strained health services and lockdowns," UNICEF Executive Director Henrietta Fore said.

"It is hard to imagine how much the coronavirus pandemic has recast motherhood" Fore said.

UNICEF said its analysis was based on data from World Population Prospects 2019 of the UN Population Division.

An average full-term pregnancy typically lasts a complete 9 months, or 39 to 40 weeks. For the purposes of this estimate, the number of births for a 40-week period in 2020 was calculated.

The 40-week period of March 11 to December 16 is used in this estimate based upon the WHO's March 11 assessment that COVID-19 can be characterised as a pandemic.

UNICEF warned that although evidence suggests that pregnant mothers are not more affected by COVID-19 than others, countries need to ensure they still have access to antenatal, delivery and postnatal services.

Similarly, sick newborns need emergency services as they are at high risk of death. New families require support to start breastfeeding, and to get medicines, vaccines and nutrition to keep their babies healthy, it said.

"This is a particularly poignant Mother's Day, as many families have been forced apart during the coronavirus pandemic, but it is also a time for unity, a time to bring everyone together in solidarity. We can help save lives by making sure that every pregnant mother receives the support she needs to give birth safely in the months to come," Fore said.

Issuing an urgent appeal to governments and health care providers to save lives in the coming months, UNICEF said efforts must be made to help pregnant women receive antenatal checkups, skilled delivery care, postnatal care services, and care related to COVID-19 as needed.

Ensure health workers are provided with the necessary personal protective equipment and get priority testing and vaccination once a COVID-19 vaccine becomes available so that can deliver high quality care to all pregnant women and newborn babies during the pandemic, it said.

While it is not yet known whether the virus is transmitted from a mother to her baby during pregnancy and delivery, UNICEF advised all pregnant women to follow precautions to protect themselves from exposure to the virus.

Closely monitor themselves for symptoms of COVID-19 and seek advice from the nearest designated facility if they have concerns or experience symptoms. Pregnant women should also take the same precautions to avoid COVID -19 infection as other people: practice physical distancing, avoid physical gatherings and use online health services, it said.

UNICEF said even before COVID-19 pandemic, an estimated 2.8 million pregnant women and newborns died every year, or 1 every 11 seconds, mostly of preventable causes.

The agency called for immediate investment in health workers with the right training, who are equipped with the right medicines to ensure every mother and newborn is cared for by a safe pair of hands to prevent and treat complications during pregnancy, delivery and birth.

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News Network
March 3,2020

Daman, Mar 3: A BJP councillor was shot dead on Monday in the Union Territory of Daman, police said.

Salim Memon was sitting in his motorcycle showroom when three to four unidentified persons shot four to five bullets after asking a visitor there to move out, an official said quoting eye-witnesses.

While fleeing, they also shot two rounds close to this visitor who was standing outside, he said.

"Memon was rushed to a hospital in Marwad area but was declared dead on arrival. CCTV footage is being scanned to nab the culprits," said Daman Superintendent of Police Vikramjit Singh.

Memon was elected to Daman municipality as a Congress candidate but then switched over to the BJP.

Sources said Memon, who also has a land brokerage business, had come out of jail a few months back in connection with a case of rivalry.

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News Network
March 4,2020

New Delhi, Mar 4: The government on Wednesday permitted NRIs to own up to 100 per cent stake in disinvestment-bound Air India.

The decision comes at a time when the government is looking to sell 100 per cent stake sale in the national carrier.

Union minister Prakash Javadekar said the Cabinet has approved allowing Non-Residents Indians (NRIs) to hold up to 100 per cent stake in Air India.

Allowing 100 per cent investment by Non-Resident Indians (NRIs) in the carrier would also not be in violation of SOEC norms. NRI investments would be treated as domestic investments.

Under the Substantial Ownership and Effective Control (SOEC) framework, which is followed in the airline industry globally, a carrier that flies overseas from a particular country should be substantially owned by that country's government or its nationals.

Currently, NRIs can acquire only 49 per cent in Air India. Foreign Direct Investment (FDI) in the airline is also 49 per cent through the government approval route.

As per the existing norms, 100 per cent FDI is permitted in scheduled domestic carriers, subject to certain conditions, including that it would not be applicable for overseas airlines.

In the case of scheduled airlines, 49 per cent FDI is permitted through automatic approval route and any such investment beyond that level requires government nod.

On January 27, the government came out witha Preliminary Information Memorandum (PIM) for Air India disinvestment. It has proposed selling 100 per cent stake in Air India along with budget airline Air India Express and the national carrier's 50 per cent stake in AISATS, an equal joint venture with Singapore Airlines.

Under the latest disinvestment plan, the successful bidder would have to take over only debt worth Rs 23,286.5 crore while the liabilities would be decided depending on current assets at the time of closing of the transaction.

This is the second attempt by the government in as many years to divest Air India, which has been in the red for long.

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