No online sale of medicines till norms in place, says HC

Agencies
December 18, 2018

New Delhi, Dec 18: The Delhi High Court on Tuesday said its stay on sale of drugs and prescription medicines by online pharmacies will continue till rules are framed to regulate such entities.

A bench of Chief Justice Rajendra Menon and Justice V K Rao said that "once the rules come into play, you (online pharmacies) can start selling it (medicines). Problem is that today there are no rules regulating it".

The observations by the bench were made while hearing the applications moved by some online pharmacies seeking to be impleaded in the matter.

The pharmacies urged the court to remove the prohibition on online sale of drugs, saying they held licences and no medicines were sold illegally.

They also contended that even prescription drugs were sold only if there was a valid prescription from a doctor.

The applications for impleadment were filed in a PIL by Zaheer Ahmed seeking a ban on "illegal" sale of drugs and medicines online.

During the hearing, the petitioner informed the bench that the Madras High Court on Monday had banned online sale of medicines till the Union Health Ministry and the Central Drugs Standard Control Organisation (CDSCO) notified the proposed Drugs and Cosmetics Amendment Rules, 2018 in the gazette at the earliest by January 31.

The Madras High Court, however, kept the operation of its order in abeyance till December 20, to enable the online pharmacies to challenge the decision.

On being informed of the development, the Delhi High Court listed the matter for hearing on December 20.

In his petition, Ahmed has said that the online illegal sale of medicines would lead to a drug epidemic, drug abuse and mis-utilisation of habit forming and addictive drugs.

It has claimed that the Ministry of Health, CDSCO and an expert committee appointed by the drug consultative committee have already concluded that the online sale of medicines was in contravention of the provisions of Drugs and Cosmetics Act, 1940 and the other allied laws.

Still lakhs of drugs are being sold on the Internet every day, it has said, adding that some of the drugs/ medicines contain narcotic and psychotropic substance and some can cause antibiotic resistant-bacteria which is a threat not only to the patient but to the humanity at large.

"It is a matter of public knowledge that e-commerce websites have been caught on numerous occasions of selling fake products. Unlike consumer items, drugs are extremely potent substances and consuming wrong dose or fake medicine can have fatal consequences on the patient," it said.

The petition said that as of now there is no mechanism to control the sale of medicines on the Internet and this puts health and lives of people at a high risk and affects their right to a safe and healthy life under Article 21 of the Constitution.

"Online pharmacies are operating without a drug licence and cannot be regulated in the present regime. Unregulated and unlicensed sale of medicines will increase risk of spurious, misbranded and sub-standard drugs being sold," the plea has said.

The plea has sought direction to the authorities to take action against the entities distributing, selling or exhibiting drugs on the internet.

It has also sought direction for constitution of an expert committee to find out the total number of websites which are distributing and selling the drugs in the country and to impose a ban on the online sale and purchase of medicines.

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Agencies
July 4,2020

The Union health ministry on Friday revised the dosage of anti-viral drug remdesivir to be administered to coronavirus patients in the moderate stage of illness from the earlier six days to five days as it issued an updated 'Clinical Management Protocols for COVID-19'.

The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for four days (total five days), the new treatment protocols stated.

The Health Ministry on June 13 had allowed the use of remdesivir for restricted emergency use in moderate cases under "investigational therapies".

"Under emergency use authorisation, remdesivir may be considered for patients in moderate stage requiring oxygen support," the document stated.

It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, it said.

The ministry also okayed off-label application of tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating COVID-19 patients in the moderate stage of illness as "investigational therapies".

It also recommended hydroxychloroquine for patients during the early course of the disease and not for critically-ill patients.

On June 27, the ministry had included an inexpensive, widely used steroid dexamethasone in treatment protocols for COVID-19 patients in the moderate to severe stages of their illness among other therapeutic measures.

The ministry advised use of dexamethasone, which is already used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects, as an alternative choice to methylprednisolone for managing moderate to severe cases of coronavirus infection.

India's COVID-19 cases soared by over 20,000 in a day for the first time taking the country's total tally to 6,25,544 on Friday while the death toll climbed to 18,213 with 379 new fatalities, according to the Union Health Ministry data updated at 8 am.

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Agencies
July 8,2020

Probiotics that broaden the mix of helpful bacteria in the gut may help to ease depression, say researchers.

Foods that broaden the profile of helpful bacteria in the gut are collectively known as probiotics. These "good bacteria" can be taken as supplements, or found naturally in yoghurts or fermented foods.

For the findings, the research team from the University of Brighton in the UK searched for relevant studies published in English between 2003 and 2019, which looked at the potential therapeutic contribution of pre-and probiotics in adults with depression and/or anxiety disorders.

Out of an initial haul of 71 studies, just seven met all the criteria for inclusion. All 7 investigated at least one probiotic strain; four looked at the effect of combinations of multiple strains.In all, 12 probiotic strains featured in the selected studies, primarily Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidium.

One study looked at combined pre-probiotic treatment, while one looked at prebiotic therapy by itself. The studies varied considerably in their design, methods used, and clinical considerations, but all of them concluded that probiotic supplements either alone or in combination with prebiotics may be linked to measurable reductions in depression.

And every study showed a significant fall or improvement in anxiety symptoms and clinically relevant changes in biochemical measures of anxiety or depression with probiotic or combined pre-probiotic use.

Of the 12 different probiotics investigated, 11 were potentially useful, the findings showed.'Probiotics may help reduce the production of inflammatory chemicals, such as cytokines, as is the case in inflammatory bowel disease, the researchers suggested.

"They may help direct the action of tryptophan, a chemical thought to be important in the gut-brain axis in psychiatric disorders," they added.

In this way, with a better understanding of the mechanisms, probiotics may prove to be a useful tool across a wide range of conditions," the authors wrote.

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Agencies
March 15,2020

Should you let your babies "cry it out" or rush to their side? Researchers have found that leaving an infant to 'cry it out' from birth up to 18 months does not adversely affect their behaviour development or attachment.

The study, published in the Journal of Child Psychology and Psychiatry, found that an infant's development and attachment to their parents is not affected by being left to "cry it out" and can actually decrease the amount of crying and duration.

"Only two previous studies nearly 50 or 20 years ago had investigated whether letting babies 'cry it out' affects babies' development. Our study documents contemporary parenting in the UK and the different approaches to crying used," said the study's researcher Ayten Bilgin from the University of Warwick in the UK.

For the study, the researchers followed 178 infants and their mums over 18 months and repeatedly assessed whether parents intervened immediately when a baby cried or let the baby let it cry out a few times or often.

They found that it made little difference to the baby’s development by 18 months.

The use of parent’s leaving their baby to ‘cry it out’ was assessed via maternal report at term, 3, 6 and 18 months and cry duration at term, 3 and 18 months.

Duration and frequency of fussing and crying was assessed at the same ages with the Crying Pattern Questionnaire.

According to the researchers, how sensitive the mother is in interaction with their baby was video-recorded and rated at 3 and 18 months of age.

Attachment was assessed at 18 months using a gold standard experimental procedure, the strange situation test, which assesses how securely an infant is attached to the major caregiver during separation and reunion episodes.

Behavioural development was assessed by direct observation in play with the mother and during assessment by a psychologist and a parent-report questionnaire at 18 months.

Researchers found that whether contemporary parents respond immediately or leave their infant to cry it out a few times to often makes no difference on the short - or longer term relationship with the mother or the infants behaviour.

This study shows that 2/3 of mum's parent intuitively and learn from their infant, meaning they intervene when they were just born immediately, but as they get older the mother waits a bit to see whether the baby can calm themselves, so babies learn self-regulation.

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