Medicines in India may not be sold under brand names in the near future.
NEW DELHI: Medicines in India may not be sold under brand names in the near future.
In its biggest move to push generic drugs and do away with brand names, the Union health ministry has ordered states to stop issuing licence for the manufacture or sale of drugs on the basis of their brand name.
All pharmaceutical firms applying for licence to market or manufacture fixed dose combination (FDC) drugs will have to submit their generic name and not as brands with immediate effect. The move will substantially reduce medicines' prices.
For example, Crocin will cease to exist, and it will be marketed and sold as paracetamol.
Drug controller general of India Dr G N Singh said, "We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public."
He added, "We have sent the order to all state health secretaries asking them to instruct their drug licencing issuing authority to issue licences only on generic names and not on branded or trade names, which is the usual practice now. A branded drug can be 10 times more expensive than a generic variant."
The parliamentary standing committee in its recent scathing report had also expressed strong objection to the practice of issuing licences on brand names.
The matter was then taken up in the Drug Consultative Committee (DCC) meeting on July 20, 2012.
A letter written by director in the health ministry Sanjay Prasad says, "Instances were brought to the notice of the central government that the licencing authorities of many states have been granting licences for manufacture of new drugs, including FDCs, in violation of drugs and cosmetics rules."
"It was reiterated in the DCC meeting that such license for new drugs for unapproved FDCs must not be granted by any state licencing authorities," stated the letter to state health secretaries.
The ministry has been going all out to promote generic medicines. It has made mandatory for all doctors in the public sector to prescribe generic drugs and not brands. Doctors have warned that strong action will be taken against doctors found prescribing brands.
Low public sector availability forces patients to purchase medicines from private sector, where prices are usually higher.
A World Health Organization study recently found that generic medicines were available only in 20%-40% of public health clinics surveyed. In comparison, 40%-60% of private health facilities had adequate stock of generic drugs. The sub-national surveys were carried out in Chennai, Haryana, Maharashtra, Karnataka, Rajasthan and West Bengal.
WHO said, "More than half of public facilities lack essential medicines."
Around 78% of healthcare expenditure in India is out-of-pocket of which 72% is spent on medicines.
National Sample Survey Organization (NSSO) records show that the highest out-of-pocket expenditure on drugs is in Himachal Pradesh (87.95%), followed by Uttarakhand (87.75%), Bihar (84%), Rajasthan (83%), Uttar Pradesh (81.86%) and Chhattisgarh (81.38%). In larger states like Maharashtra 60% of out-of-pocket expenses are for buying drugs, Karnataka (65%), Delhi (74%), Tamil Nadu (66%), Madhya Pradesh (71%) and West Bengal (65.80%).
India is also opening Jan Aushadhi, a countrywide chain of medical stores, to make generic and other drugs available at reasonable prices.
However, only few stores have been opened in Andhra Pradesh, Delhi, Haryana, Odisha, Punjab, Rajasthan and Uttarakhand.
The health ministry is also gearing up to make "Free medicine for all through Public Health Facilities" in all government health facilities a reality from next month.
The sharp increase in prices of drugs has been the main reason for the rising costs of healthcare, which more than tripled between 1993-94 and 2006-07. Between 1993-94 and 2004-05, compared to a 67% rise in real per person income and an 82% increase in per person tax collections, real per person public health expenditure rose from Rs 84 to Rs 125. The paltry spending by states on purchasing drugs has only compounded poor patients' problems.
Drug prices have also shot up phenomenally in India over the past decade and a half.
India reported around 40% spurt in all drug prices between 1996 and 2006.
In its biggest move to push generic drugs and do away with brand names, the Union health ministry has ordered states to stop issuing licence for the manufacture or sale of drugs on the basis of their brand name.
All pharmaceutical firms applying for licence to market or manufacture fixed dose combination (FDC) drugs will have to submit their generic name and not as brands with immediate effect. The move will substantially reduce medicines' prices.
For example, Crocin will cease to exist, and it will be marketed and sold as paracetamol.
Drug controller general of India Dr G N Singh said, "We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public."
He added, "We have sent the order to all state health secretaries asking them to instruct their drug licencing issuing authority to issue licences only on generic names and not on branded or trade names, which is the usual practice now. A branded drug can be 10 times more expensive than a generic variant."
The parliamentary standing committee in its recent scathing report had also expressed strong objection to the practice of issuing licences on brand names.
The matter was then taken up in the Drug Consultative Committee (DCC) meeting on July 20, 2012.
A letter written by director in the health ministry Sanjay Prasad says, "Instances were brought to the notice of the central government that the licencing authorities of many states have been granting licences for manufacture of new drugs, including FDCs, in violation of drugs and cosmetics rules."
"It was reiterated in the DCC meeting that such license for new drugs for unapproved FDCs must not be granted by any state licencing authorities," stated the letter to state health secretaries.
The ministry has been going all out to promote generic medicines. It has made mandatory for all doctors in the public sector to prescribe generic drugs and not brands. Doctors have warned that strong action will be taken against doctors found prescribing brands.
Low public sector availability forces patients to purchase medicines from private sector, where prices are usually higher.
A World Health Organization study recently found that generic medicines were available only in 20%-40% of public health clinics surveyed. In comparison, 40%-60% of private health facilities had adequate stock of generic drugs. The sub-national surveys were carried out in Chennai, Haryana, Maharashtra, Karnataka, Rajasthan and West Bengal.
WHO said, "More than half of public facilities lack essential medicines."
Around 78% of healthcare expenditure in India is out-of-pocket of which 72% is spent on medicines.
National Sample Survey Organization (NSSO) records show that the highest out-of-pocket expenditure on drugs is in Himachal Pradesh (87.95%), followed by Uttarakhand (87.75%), Bihar (84%), Rajasthan (83%), Uttar Pradesh (81.86%) and Chhattisgarh (81.38%). In larger states like Maharashtra 60% of out-of-pocket expenses are for buying drugs, Karnataka (65%), Delhi (74%), Tamil Nadu (66%), Madhya Pradesh (71%) and West Bengal (65.80%).
India is also opening Jan Aushadhi, a countrywide chain of medical stores, to make generic and other drugs available at reasonable prices.
However, only few stores have been opened in Andhra Pradesh, Delhi, Haryana, Odisha, Punjab, Rajasthan and Uttarakhand.
The health ministry is also gearing up to make "Free medicine for all through Public Health Facilities" in all government health facilities a reality from next month.
The sharp increase in prices of drugs has been the main reason for the rising costs of healthcare, which more than tripled between 1993-94 and 2006-07. Between 1993-94 and 2004-05, compared to a 67% rise in real per person income and an 82% increase in per person tax collections, real per person public health expenditure rose from Rs 84 to Rs 125. The paltry spending by states on purchasing drugs has only compounded poor patients' problems.
Drug prices have also shot up phenomenally in India over the past decade and a half.
India reported around 40% spurt in all drug prices between 1996 and 2006.
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