By PTI
NEW DELHI: The Supreme Court Thursday was told by an NGO that the Central Board of Direct taxes has accused the Pharma company manufacturing popular Dolo tablets, an anti-inflammatory, fever reducer drug, of distributing Rs 1000 crore freebies to doctors for prescribing a dosage of its 650 mg tablets.
A bench of Justices DY Chandrachud and AS Bopanna was told by senior advocate Sanjay Parikh and advocate Aparna Bhat, appearing for petitioner ‘Federation of Medical and Sales Representatives Association of India’, that the market price of any tablet up to 500mg is regulated under price control mechanism of the government but the price of drug above 500mg can be fixed by manufacturer Pharma Company.
He said that to ensure a higher profit margin, the company distributed freebies to doctors to prescribe the Dolo drug of dosage 650mg capacity.
Parikh added that it is an “irrational dose combination” and said that he would like to bring more such facts to the knowledge of the court after a response is filed by the Centre.
Justice Chandrachud said, “What you are saying is music to my ears. This is exactly the drug that I had when I had COVID recently. This is a serious issue and we will look into it”.
The bench asked Additional Solicitor General KM Nataraj to file his response to the plea in ten days and gave one week time thereafter to Parikh to file his rejoinder.
It listed the matter for further hearing on September 29, 2022.
A counsel sought permission from the court to file an intervention on behalf of the Pharma companies, which the court allowed saying it would like to hear them also on the issue.
On March 11, the top court agreed to examine a plea seeking direction to the Centre for formulating a Uniform Code of Pharmaceutical Marketing Practices to curb unethical practices of Pharma companies and ensure an effective monitoring mechanism, transparency, accountability as well as consequences for violations.
The top court had said that it wants to know what the government has to say on this issue.
Parikh had said that this is an important issue in the public interest and there is a recent judgement by this court which said that bribe-giver or bribe-taker both are prohibited.
He had submitted that Pharmaceutical companies are saying that they are not liable as the bribe-takers are the doctors and in foreign countries, they have legislation to curb these unethical marketing practices.
Parikh said that the government should look into it and the code should be made statutory in nature as “we all know what happened with Remdesivir injections and other drugs of those combinations”.
The top court had then asked the petitioner why can’t a representation to the government be made to which Parikh had said they have already done it.
He had said that they have been pursuing the issue with the government since 2009 and till the time the government comes out with the code to regulate, this court may lay down some guidelines.
The plea filed through advocate Aparna Bhat sought direction that till an effective law is enacted as prayed, this Court may lay down the guidelines to control and regulate unethical marketing practices by pharmaceutical companies or in the alternative make the existing Code binding with proper and reasonable modifications/additions, which should be followed by all the authorities/courts under Articles 32, 141, 142 and 144 of the Constitution.
The plea added that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 prescribe a Code of conduct for doctors in their relationship with the pharmaceutical and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from Pharmaceutical companies.
“This Code is enforceable against doctors, however, does not apply to drug companies, leading to anomalous situations where doctors’ licenses are cancelled for misconduct which is actuated, encouraged, aided, and abetted by pharma companies. The pharma companies go scot-free”, it added.
The plea said that though termed as ‘sales promotion,’ in fact, direct or indirect advantages are offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits) in exchange for an increase in drug sales.
It said that unethical drug promotion can adversely influence doctors’ prescription attitudes and harm human health by over-use/ over-prescription of drugs, prescription of higher doses of drugs than necessary, prescription of drugs for a longer period than necessary, prescription of a higher number of drugs than necessary and prescription of an irrational combination of drugs.
It said that pharmaceutical companies use high-pressure promotion practices to lure physicians to prescribe irrational combination drugs to generate massive sales.
NEW DELHI: The Supreme Court Thursday was told by an NGO that the Central Board of Direct taxes has accused the Pharma company manufacturing popular Dolo tablets, an anti-inflammatory, fever reducer drug, of distributing Rs 1000 crore freebies to doctors for prescribing a dosage of its 650 mg tablets.
A bench of Justices DY Chandrachud and AS Bopanna was told by senior advocate Sanjay Parikh and advocate Aparna Bhat, appearing for petitioner ‘Federation of Medical and Sales Representatives Association of India’, that the market price of any tablet up to 500mg is regulated under price control mechanism of the government but the price of drug above 500mg can be fixed by manufacturer Pharma Company.
He said that to ensure a higher profit margin, the company distributed freebies to doctors to prescribe the Dolo drug of dosage 650mg capacity.
Parikh added that it is an “irrational dose combination” and said that he would like to bring more such facts to the knowledge of the court after a response is filed by the Centre.
Justice Chandrachud said, “What you are saying is music to my ears. This is exactly the drug that I had when I had COVID recently. This is a serious issue and we will look into it”.
The bench asked Additional Solicitor General KM Nataraj to file his response to the plea in ten days and gave one week time thereafter to Parikh to file his rejoinder.
It listed the matter for further hearing on September 29, 2022.
A counsel sought permission from the court to file an intervention on behalf of the Pharma companies, which the court allowed saying it would like to hear them also on the issue.
On March 11, the top court agreed to examine a plea seeking direction to the Centre for formulating a Uniform Code of Pharmaceutical Marketing Practices to curb unethical practices of Pharma companies and ensure an effective monitoring mechanism, transparency, accountability as well as consequences for violations.
The top court had said that it wants to know what the government has to say on this issue.
Parikh had said that this is an important issue in the public interest and there is a recent judgement by this court which said that bribe-giver or bribe-taker both are prohibited.
He had submitted that Pharmaceutical companies are saying that they are not liable as the bribe-takers are the doctors and in foreign countries, they have legislation to curb these unethical marketing practices.
Parikh said that the government should look into it and the code should be made statutory in nature as “we all know what happened with Remdesivir injections and other drugs of those combinations”.
The top court had then asked the petitioner why can’t a representation to the government be made to which Parikh had said they have already done it.
He had said that they have been pursuing the issue with the government since 2009 and till the time the government comes out with the code to regulate, this court may lay down some guidelines.
The plea filed through advocate Aparna Bhat sought direction that till an effective law is enacted as prayed, this Court may lay down the guidelines to control and regulate unethical marketing practices by pharmaceutical companies or in the alternative make the existing Code binding with proper and reasonable modifications/additions, which should be followed by all the authorities/courts under Articles 32, 141, 142 and 144 of the Constitution.
The plea added that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 prescribe a Code of conduct for doctors in their relationship with the pharmaceutical and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from Pharmaceutical companies.
“This Code is enforceable against doctors, however, does not apply to drug companies, leading to anomalous situations where doctors’ licenses are cancelled for misconduct which is actuated, encouraged, aided, and abetted by pharma companies. The pharma companies go scot-free”, it added.
The plea said that though termed as ‘sales promotion,’ in fact, direct or indirect advantages are offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits) in exchange for an increase in drug sales.
It said that unethical drug promotion can adversely influence doctors’ prescription attitudes and harm human health by over-use/ over-prescription of drugs, prescription of higher doses of drugs than necessary, prescription of drugs for a longer period than necessary, prescription of a higher number of drugs than necessary and prescription of an irrational combination of drugs.
It said that pharmaceutical companies use high-pressure promotion practices to lure physicians to prescribe irrational combination drugs to generate massive sales.
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