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Stop sale of Johnson & Johnson baby shampoo: Child rights body to states

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Johnson-Johnson
The child rights body has also asked the Drug Control Organisation Rajasthan to send the test report of Johnson & Johnson’s baby talcum powder at the earliest

New Delhi, April 27: The National Commission for Protection of Child Rights (NCPCR) has written to the chief secretaries of all states and Union Territories asking them to stop the sale of Johnson & Johnson baby shampoo in their respective states in view of the findings of the sample testing report from the Rajasthan drug control officer.

While seeking an update in the matter from states, NCPCR in its order recommends that the sale of the product may be stopped till further notice.

However, Johnson & Johnson has stated that they are not aware of any directions by the NCPCR and will only come to a conclusion after a re-testing process at the Central Drugs Laboratory.

“We did not accept the interim results of the government analyst that were based on unknown and unspecified methods and have contested these interim test results. We will await the results and conclusions of the re-testing process at the Central Drugs Laboratory. We are not aware of any directions from NCPCR. It must be noted that any such directions, under the law, can only be issued under certain prescribed conditions”; Times of India quoted J&J spokesperson as saying.

In taking its decision, the NCPCR took note of a Rajasthan government report and the results quoted of the Government Analyst Drug Testing Laboratory in Jaipur which found samples of J&J baby shampoo “not of standard quality as presence of formaldehyde was confirmed”. The child rights body has also asked the Drug Control Organisation Rajasthan to send the test report of Johnson & Johnson’s baby talcum powder at the earliest.

The recommendations come as a follow-up to a hearing held on April 15 on the summons issued in the matter to five states – Rajashthan, Madhya Pradesh, Jharkhand, Assam and Andhra Pradesh. The summons were over no response to repeated letters on status of sample tests sought to settle the safety concerns raised regarding use of Johnson & Johnson baby care products -specifically its talcum powder and shampoo.

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Disaster

Coronavirus crisis may get ‘worse and worse and worse’, warns WHO

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Tedros Adhanom Ghebreyesus WHO

GENEVA : The raging coronavirus pandemic has the potential to get far worse if all nations do not adhere to basic healthcare precautions, the World Health Organization (WHO) warned on Monday.

“Let me be blunt, too many countries are headed in the wrong direction, the virus remains public enemy number one,” Director General Tedros Adhanom Ghebreyesus told a virtual briefing from WHO headquarters in Geneva.

“If basics are not followed, the only way this pandemic is going to go, it is going to get worse and worse and worse. But it does not have to be this way.”

Infections rose above 13 million across the world on Monday, according to a Reuters tally, climbing by one million in just five days in a pandemic that has killed more than half a million people.

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Cities

Doctor who managed Goa’s only Covid hospital tests positive

The state currently has more than 900 active Covid-19 cases, with 17 fatalities linked to coronavirus.

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Dr Gomes

Panaji, July 13 : Dr. Edwin Gomes, who had emerged as the face of Goa”s Covid-19 treatment and care effort, and had served as the in-charge of medication of patients at the state’s only designated Covid-19 hospital, has tested positive for the viral infection, a government spokesperson said.

“Dr. Gomes has been admitted to a state government facility for doctors infected by coronavirus,” the spokesperson said.

Gomes, 58, is also the head of medicine at the state”s only medical college, the Goa Medical College, and had last week ended his unbroken 98-day shift at the designated Covid-19 hospital.

The state currently has more than 900 active Covid-19 cases, with 17 fatalities linked to coronavirus.

Chief Minister Pramod Sawant has said that “four to five” Covid-19 patients who died, were suffering from cancer. “Eight to 10 patients were above the age of 80 years, while one also died of liver failure. The death rate has increased due to co-morbid conditions,” Sawant told reporters at the State Secretariat.

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Disaster

Glenmark cuts Fabiflu price by 27%

On June 20, Glenmark announced that it received manufacturing and marketing approval from India”s drug regulator for FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.

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Glenmark Fabiflu

New Delhi, July 13 : Glenmark Pharmaceuticals has announced that it has commenced a Post Marketing Surveillance (PMS) study on FabiFlu to closely monitor the efficacy and safety of the drug in 1000 Covid patients that are prescribed with the oral antiviral.

Further, Glenmark has announced a price reduction of 27 per cent for FabiFlu. The new MRP is Rs 75 per tab from the earlier Rs 103 per tab.

The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API and formulations are made at Glenmark”s facilities in India, the benefits of which are being passed on to patients in the country.

Glenmark has successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through its own in-house R&D team within the country, ensuring self-reliance with regard to long term production and manufacturing.

Commenting on these developments, Alok Malik, Senior Vice President & Head – India business, Glenmark Pharmaceuticals said, “We expect this post marketing surveillance study to shed more light on the drug”s clinical effectiveness and safety in a large cohort of patients prescribed FabiFlu. Our priority from the start of this pandemic has been to offer patients in India an effective treatment for COVID-19, while also ensuring accessibility to the masses.

“Our internal research shows us that we launched FabiFlu in India at the lowest market cost as compared to the cost of Favipiravir in other countries where it is approved. And now we hope that this further price reduction will make it even more accessible for patients across the country.”

Despite investing significantly in R&D, clinical trials and the manufacturing of FabiFlu (API and formulations), Glenmark has managed to keep the pricing of FabiFlu lower as compared to its price in other countries.

FabiFlu in India was originally launched at Rs 103 per tablet, while, its price in Indian Rupees is higher in the remaining countries like Rs 600 in Russia, Rs 378 in Japan, Rs 350 in Bangladesh and Rs 215 in China.

On June 20, Glenmark announced that it received manufacturing and marketing approval from India”s drug regulator for FabiFlu, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.

The manufacturing and marketing approval was granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India. The approval”s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.

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