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
April 25,2024

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Electronics Corporation of India Ltd and Bharat Electronics Ltd have refused to disclose the names and contact details of the manufacturers and suppliers of various components of EVMs and VVPATs under the RTI Act citing "commercial confidence", according to RTI responses from the PSUs to an activist.

Activist Venkatesh Nayak had filed two identical Right To Information applications with the ECIL and BEL, seeking the details of the manufacturers and suppliers of various components used in the assembling of the electronic voting machines (EVMs) and voter-verifiable paper audit trail (VVPATs).

The VVPAT is an independent vote verification system which enables electors to see whether their votes have been cast correctly.

The ECIL and the BEL, public sector undertakings under the Ministry of Defence, manufacture EVMs and VVPATs for the Election Commission.

Nayak also sought a copy of the purchase orders for the components from both PSUs.

"Information sought is in commercial confidence. Hence details cannot be provided under Section 8(1)(d) of the RTI Act," BEL said in its response.

A similar response was sent by ECIL which said the details requested are related to a product which is being manufactured by ECIL, and third party in nature.

"Disclosing of details will affect the Competitive position of ECIL. Hence, Exemption is claimed under section 8(1) (d) of RTI ACT, 2005," it said.

In response to the purchase order copies, ECIL's central public information officer said the information is "voluminous" which would disproportionately divert the resources of the Public Authority.

"Further, the information will give away the design details of EVM components. The same may pose a danger to the machines produced. Hence, the exemption is claimed U/s 7(9) and under section 8(1)(d) of RTI Act, 2005," ECIL said.

Section 8(1)(d) of the RTI Act exempts from disclosure the information, including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party, unless the competent authority is satisfied that larger public interest warrants the disclosure of such information.

Section 7(9) of the Act says the information shall ordinarily be provided in the form in which it is sought unless it would disproportionately divert the resources of the public authority or would be detrimental to the safety or preservation of the record in question.

"I don't know whose interests they are trying to protect against the right to know of close to a billion-strong electorate. ECIL said that disclosure of the purchase orders will reveal the design details of the components and this may pose a danger to the machines produced. ECIL did not upload even a signed copy of its reply on the RTI Online Portal," Nayak said.

He said it is reasonable to infer that the two companies are not manufacturing every single item of the EVM-VVPAT combo or else the two companies would have replied that they are manufacturing all these components internally without any outsourcing being involved.

"But the electorate is expected to take everything about the voting machines based on what the ECI is claiming in its manuals and FAQs," Nayak said.

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News Network
April 24,2024

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Pro-Gaza US protesters in New York's Columbia University say they will stay put despite the university's harassment and police crackdown.

The protesters said they refuse to concede to "cowardly threats and blatant intimidation" by university administration, asserting that they will continue to peacefully protest.

Columbia University threatened the students with the national guard after refusing to bargain in good faith.

The university announced a midnight deadline for talks regarding the removal of pro-Palestine encampments on the varsity campus, warning that their campsite will be forcefully cleared by police if no agreement is reached.

The university campus is being used as a campsite for hundreds of pro-Palestine protesters and other activists, who have gathered and set up numerous tents.

Pro-Palestinian protests at colleges have demanded that their universities divest from corporations doing business with Israel or profiting off the war in Gaza. At Columbia, protesters have also asked the university to end a dual-degree program with Tel Aviv University.

The deadline was announced by Columbia University President Minouche Shafik late Tuesday, as authorities across major American universities have launched their repression campaigns against the pro-Palestinian protests on campuses, amid rising anger over US's support for Israel. 

Shafik has issued a midnight deadline to protesters and organizers, warning that failure to comply will result in the forcible clearance of the camp by the New York Police Department (NYPD).

The university has engaged in discussions with student leaders behind the protests, which are part of a series of protests taking place at various colleges nationwide and resulting in multiple arrests.

The purpose of these talks is to address the encampment on the west lawn of Columbia's Morningside Heights campus.

American universities are grappling with the challenge of maintaining a delicate balance between the right to protest and freedom of speech, while also ensuring campus rules and safety, as tensions surrounding the ongoing war in Gaza continue to permeate across campuses.

Meanwhile, Shafik underscored the importance of free speech and the right to demonstrate, but highlighted significant safety issues, disruptions to campus activities, and a strained environment due to the encampment. She firmly stated that any form of intimidation, harassment, or discrimination would not be accepted.

The arrest of more than 100 protesters at Columbia University last week led to more campus demonstrations, at New York University, Yale, and the University of California, Berkeley.

Palestinian university professor Sami al-Arian said what is happening across US university campuses is unprecedented.

Al-Arian said, "I lived four decades in the US, 28 years of which were in academic settings. During my time, it was a very challenging struggle to present an anti-Zionist narrative."

"But the passion, courage, humanity, creativity, and determination displayed these days by students across US campuses make me proud. The Zionist grip on US society is weakening and waning."

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News Network
April 26,2024

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An Indian-origin woman studying at the prestigious Princeton University in the US is among two students arrested over pro-Palestine protests on the campus, reports student and alumni newspapers.

Tamil Nadu-born Achinthya Sivalingan and Hassan Sayed were arrested after the protesters set up tents for an encampment in a university courtyard early Thursday morning, according to the Princeton Alumni Weekly (PAW).

The two graduate students were arrested on charge of trespassing and have been "immediately barred from the campus", said Jennifer Morrill, a university spokesperson, adding that setting up tents on the campus violated university policy.

However, they have not been evicted and will be allowed into their housing, another varsity spokesperson Michael Hotchkiss confirmed to the Daily Princetonian.

Ms Sivalingam is a student of Masters in Public Affairs in International Development at Princeton while Mr Sayed is a PhD candidate there.

In a statement, Morill said the students were given "repeated warnings from the Department of Public Safety to cease the activity and leave the area" and they now face disciplinary action. After their arrest, the other protesters "voluntarily" packed away their camping gear, she added.

Hotchkiss said the university did not evict anyone on Thursday and that the university allows students barred from campus to stay in their university-owned housing.

The undergraduate students were warned against occupation and encampment exercises in an email Wednesday, according to the Daily Princetonian.

Princeton students, faculty and community members, and even outsiders were part of the demonstration, the PAW cited organizers of the protest as saying. Large, white tents were set up nearby for upcoming reunions and other events.

A student who chose to be identified only as Urvi termed the arrests as "violent", which included the students being zip-tied around their wrists. The university, however, contested this and said the officers did not use any force and the arrests were made without any resistance.

Pro-Palestine protests have rocked the top US universities as thousands of students have hit their campuses to demonstrate against the Gaza deaths due to Israel’s inhuman military operation. 

The protests, which began at Columbia University in New York, have to colleges across the country and saw hundreds of students confronting cops and raising pro-Palestine slogans. The protesters have been calling on their universities to divest from companies that profit from the Gaza war and advocate an immediate ceasefire.

Who is Achinthya Sivalingan?

1. Achinthya Sivalingan was born in Coimbatore, Tamil Nadu and was raised in Columbus, Ohio.

2. She is pursuing a Master of Public Affairs (MPA) degree in International Development at Princeton University. Before that, Ms Sivalingan studied world politics and economics at Ohio State University and was also an Intern at Harvard Law School. 

3. Ms Sivalingan has significant experience in policy issues, having worked with civil society organisations, the legal system, politics, movement building, and private philanthropy. Her previous roles include supporting policy and advocacy work for climate adaptation, agricultural development, and nutrition portfolios at the Bill and Melinda Gates Foundation. 

4. Ms Sivalingan has worked on a congressional campaign in Ohio's third district and also contributed to land rights and policy initiatives in India at the Centre for Policy Research. 

5. She has been banned from Princeton over pro-Palestine protests and is now facing disciplinary action. 

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