India's psychotropic drug market flooded with unapproved FDCs:

India's psychotropic drug market flooded with unapproved FDCs: Study

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A recent study has revealed that over 60 per cent of the fixed-dose combination (FDC) drugs used for treating mental health disorders in India are “unapproved” and lack proven therapeutic value, according to a report by The Print. This finding emerges amidst a significant crackdown on FDC drugs by the nation’s top drug regulatory body.

The study, which appeared in the Journal of Pharmaceutical Policy and Practice this month, involved researchers from the UK, India, and Qatar. It found that unapproved FDCs made up 60.3 per cent of psychotropic FDC sales in 2020, a slight decrease from 69.3 per cent in 2008 but still alarmingly high.

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FDCs, which are a blend of two or more drugs in one pharmaceutical form such as a capsule, are often available in India without the approval of the Central Drugs Standard Control Organisation (CDSCO). Instead, these drugs are approved for manufacture by state authorities without adequate proof of safety and efficacy.

The study highlighted that "psychotropic FDCs are heavily marketed in India despite their exclusion from Indian clinical guidelines, minimal evidence supporting their therapeutic benefits, concerns about potential harm, and limited usage in other markets."

The persistence of unapproved FDC drugs in the market, making up a substantial portion of psychotropic FDC sales, raises concerns as these drugs have not undergone rigorous safety and efficacy evaluations, the researchers added.

Apex drug regulatory body framing guidelines for proper disposal of expired and unused medicines to prevent misuse

Apex drug regulatory body framing guidelines for proper disposal of expired and unused medicines to prevent misuse

3 min read

28 Aug 2024, 07:49 PM IST

Priyanka Sharma

New Delhi: The Central Drugs Standard Control Organization (CDSCO), India's apex drug regulator, is framing guidelines for disposal of expired and unused medicines to prevent their misuse and to curb anti-microbial resistance (AMR) in drugs.

AMR occurs when bacteria, viruses and fungi become immune to drugs over time, making it harder to treat ailments. This move assumes significance given that AMR has become a public health threat in India.

“This initiative also aims to curb the anti-microbial resistance of drugs due to wrong methods of discharging drugs and chemicals into environment which is a threat to the environment, causing serious problems to aquatic life and negative impact on the ecosystem," said a government official aware of the matter.

A report on the matter by a sub-committee of the government’s Drugs Consultative Committee (DCC), along with the guidance document on safe disposal of unused/expired medicines, was discussed in detail by the DCC.

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Why Employers are finding alternate professionals Or prepare their own skilled work force?From general store Chemist to hospital and industry and now skill development program by GOI - all are opting alternate workforce.Why Indian pharma academe has failed to produce even one single Pharmacist in the past 60+ years worth the name who is fit enough to serve professionally in the Govt or Pvt pharmacy ?

Why Employers are finding alternate professionals Or prepare their own skilled work force?

From general store Chemist to hospital and industry and now skill development program by GOI - all are opting alternate workforce.

Why?

Indian pharma academe has failed to produce even one single Pharmacist in the past 60+ years worth the name who is fit enough to serve professionally in the Govt or Pvt pharmacy. 

The curriculum and teaching technique and environment and teaching materials used are so irrelevant and irrational and equally confusing to teachers, students and the people at large. Students don't know where they are heading, Teachers do not know what professional they are preparing, Parents do not know what their ward is going to become?

Result is focus only on exam and pass adopting cut n paste TECHNOLOGY☺

A lengthy list of jobs are shown as prospects to convince on scope.

But everywhere these pharmacists are novice!

How can the employer and the system depend on such persons ?

It becomes natural to find altrnate skilled persons?

If this is to be stopped, the academe should change their work and thought style.

👉Stop class room cut n paste teaching and answering.

👉Let the students learn from live environment .

👉Teach pharmacy in hospital and Community ambience.

👉Teacher should discuss live prescriptions with lab reports and teach logistics and dispensing live in hospitals

Please pardon me if you feel I am rude.

Good wishes

POV : Bhagwan PS

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