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Stricter licence norms soon
Soon, getting a licence for manufacturing prescription drugs — which can only be prescribed by a doctor and cannot be sold over-the-counter (OTC) — will come with a strict condition.
Drug manufacturers of such Schedule H category drugs under the Drugs and Cosmetic Rules cannot advertise their medicines through any medium, lest it promotes self-medication among consumers.
A high-level panel of the Union Health Ministry on technical matters has approved the condition which intends to curb rampant misuse of antibiotics, the main cause for anti-microbial resistance which is posing a huge challenge to the health system.
The Drug and Technical Advisory Board (DTAB) headed by the Drug Controller General of India (DCGI) GN Singh will soon send the proposal in this regard to the Health Ministry for final approval, said sources in the Ministry.
However, shockingly, the move came only after a rap by a Parliamentary Panel on Health which noted that some manufacturers advertise prescription drugs (Schedule H) in the media in violation of the norms.
“Based on incomplete information, patients tend to self-medicate, more so because such medicines are generally available without prescription,” the panel pointed out in its recent report on the working of the Central Drugs Standard Control Organisation (CDSCO).
Such practices can adversely impact not only the health of individuals, but even communities and countries. For example, misuse of antibiotics can lead to bacterial resistance with serious consequences for public health, it said.
The DTAB considered tightening of the licencing norms after it realised that the issue of advertisements of drugs does not come under the purview of the Drugs and Cosmetics Act, 1940, but it was necessary in public interest that the manufacturers do not indulge in advertisement of drugs included under the prohibited category.
Apart from banning such marketing practices and penalizing offenders, the panel had also favoured sharpening of teeth to the Drugs and Magic remedies (Objectionable Advertisements) Act.
Moreover, India does not still have a workable national antibiotic policy which could ban OTC sale of the anti-biotic and prescription drugs.
“That may partly explain why drug resistance to many powerful antibiotics is increasing in a short span of time. For instance, if carbapenem resistance in 2008 was 2-3 per cent in some hospitals in India, it has now increased to 20-25 per cent,” says a scientist from the ICMR.
Soon, getting a licence for manufacturing prescription drugs — which can only be prescribed by a doctor and cannot be sold over-the-counter (OTC) — will come with a strict condition.
Drug manufacturers of such Schedule H category drugs under the Drugs and Cosmetic Rules cannot advertise their medicines through any medium, lest it promotes self-medication among consumers.
A high-level panel of the Union Health Ministry on technical matters has approved the condition which intends to curb rampant misuse of antibiotics, the main cause for anti-microbial resistance which is posing a huge challenge to the health system.
The Drug and Technical Advisory Board (DTAB) headed by the Drug Controller General of India (DCGI) GN Singh will soon send the proposal in this regard to the Health Ministry for final approval, said sources in the Ministry.
However, shockingly, the move came only after a rap by a Parliamentary Panel on Health which noted that some manufacturers advertise prescription drugs (Schedule H) in the media in violation of the norms.
“Based on incomplete information, patients tend to self-medicate, more so because such medicines are generally available without prescription,” the panel pointed out in its recent report on the working of the Central Drugs Standard Control Organisation (CDSCO).
Such practices can adversely impact not only the health of individuals, but even communities and countries. For example, misuse of antibiotics can lead to bacterial resistance with serious consequences for public health, it said.
The DTAB considered tightening of the licencing norms after it realised that the issue of advertisements of drugs does not come under the purview of the Drugs and Cosmetics Act, 1940, but it was necessary in public interest that the manufacturers do not indulge in advertisement of drugs included under the prohibited category.
Apart from banning such marketing practices and penalizing offenders, the panel had also favoured sharpening of teeth to the Drugs and Magic remedies (Objectionable Advertisements) Act.
Moreover, India does not still have a workable national antibiotic policy which could ban OTC sale of the anti-biotic and prescription drugs.
“That may partly explain why drug resistance to many powerful antibiotics is increasing in a short span of time. For instance, if carbapenem resistance in 2008 was 2-3 per cent in some hospitals in India, it has now increased to 20-25 per cent,” says a scientist from the ICMR.
