<div><em>Sale of no goods online had stirred any controversy as that of medicines. With the law yet to be updated to govern online pharmacy, several e-tailers have jumped on to the pharmacy bandwagon. This has led to a huge outcry from the All India Organisation of Chemists and Druggists. Meanwhile, the government has set up a panel to go into the entire gamut of issues. </em><br /><br />Early this year, about 20 websites, including Amazon, Flipkart, Snapdeal and Shopclues, were found soliciting orders for online sale of drugs. More than 45 drugs were listed in one portal alone. <br /><br />Sensing violation of laws, the Maharashtra State Drug Controller raided the business premises of Snapdeal in Mumbai and seized “prescription only” brands like Ascoril of Glenmark (containing prescription-only ingredients like terbutaline or codeine, a derivative of narcotic morphine) and Vigora of German Remedies (containing sildenafil used in male impotence with some very serious and occasionally fatal side effects). <br /><br />Telangana also sought explanation from similar websites operating out of their jurisdiction. The sales were reportedly stopped.<br /><br />In the aftermath, the Drugs Consultative Committee, comprising state-level drug regulators, meeting on July 24 formed a seven-member sub-committee to “examine the issue of sale of drugs on the internet in the light of practices being followed in the developed countries.” <br /><br />Drugs Controller General of India (DCGI) Dr G N Singh reportedly stated that “online scenario may change,” thereby alluding to the possibility of legalising web-based sale of medicines. This infuriated the All India Organisation of Chemists and Druggists (AIOCD), and its 7.5 lakh members have now called for a nationwide strike on October 14.<br /><br />The drug regulation in India is bifurcated between Central Drugs Standard Control Organisation (CDSCO), headed by DCGI, and state-level drug authorities who function under their respective state governments and hence are not under CDSCO.<br /><br />In general, CDSCO has the power to approve new drugs, clinical trials and issue licences for blood products. State controllers are empowered to issue licences and monitor pharmaceutical producers, wholesale and retail traders. Thus, the sale of drugs lies exclusively within the purview of state controllers.<br /><br />At present, producers are allowed to sell drugs only to licensed dealers, registered doctors and hospitals. Retailers are licensed only if they have adequately equipped premises for storage of temperature-sensitive medicines and have qualified on-site pharmacists to dispense drugs against prescriptions by registered medical practitioners as well as advise patients about the right dosing schedule. <br /><br />The rules also permit sale of certain specified formulations from motor vehicles and specified simple remedies by general shops in villages with population less than 1,000 in the absence of a licensed drug retailer. <br /><br />However, there is no provision to deliver drugs to customers by mail or courier, which by their very nature lack appropriate storage conditions.<br /><br />Selling prescription drugs by persons other than pharmacists is a criminal offence that can land the offender in prison for six months as per the Pharmacy Act. It is obvious that many rules governing sale of drugs were being violated by portals and even by manufacturers or their authorised distributors.<br /><br />Flouting rules<br /><br />Drugs were supplied to websites not licensed by drug regulators. Stocks were kept at unauthorised premises not adequately equipped for temperature control. The possibility of medicines turning sub-standard could not be ruled out.<br /><br />Samples for quality and authenticity of drugs could not be collected routinely by state inspectors. The possibility of fake, counterfeit and sub-standard brands being dispensed could not be ruled out.<br /><br />Portals advertised prescription drugs to lay public in violation of Drugs and Magic Remedies Act which permits dissemination of information on drugs confidentially to only registered medical practitioners. <br /><br />Websites handed over drugs to unauthorised carriers, both postal and/or courier firms and portal’s own delivery staff that did not have facilities for temperature or moisture control during transit. Hence, the potency of such drugs could be compromised.<br /><br />Portals could not and did not check prescriptions by registered medical practitioners and did not endorse the same to comply with the law. Medicines were not dispensed by or under the supervision of pharmacists.<br /><br />Scrutinising doctors’ prescription by websites located outside the place of residence of patients is virtually impossible in India since every doctor needs to be registered by the state medical council of the area in which they practice. <br /><br />For example, if a doctor has obtained medical qualifications in Kerala and is registered by the Kerala Medical Council but in order to practice in Karnataka or Delhi, he needs to be registered again by the Karnataka/Delhi Medical Councils. <br /><br />How would a website located, say in Mumbai, check if (a) the scanned copy, even if obtained, is genuine and not tampered, (b) medical council registration corresponds to the place of residence of the patient and (c) how would the original prescription be endorsed as required by law for supplies made so that additional stocks are not obtained on the strength of the same prescription, more so in the case of psychotropic drugs such as anti-anxiety and anti-depressant which are not only misused for recreational purposes but can be fatal in over-dose.<br /><br />Temperature control is a tricky business. It is true that legally only some drugs, such as antibiotics, insulin, vaccines etc., need to be stored in refrigerators but manufacturers routinely advise that their formulations should be stored in “cool, dry place.” Others such as Ranbaxy go as far as to advise that its anti-asthma brand Synasma (doxofylline) should be “stored below 25 degree C.” The implication is that if the drug loses its potency due to higher temperature, then producer will not be legally liable.<br /><br />The websites were luring customers by offering a 10 per cent discount on MRP. But by not meeting stiff standards on premises and staff, expenses of websites are much lower coupled with larger discount from drug producers who also saved on the 30 per cent trade discount to distributors and retailers.<br /><br />Copying practices in e-commerce in pharmaceutical retail field from developed countries will harm patients due to different laws coupled with the federal structure in India. For instance, in Britain only the General Medical Council is responsible for registration of doctors, in India there are scores of state councils. <br /><br />In Britain, every registered doctor can practice anywhere, in India, s/he can only practice in the state where they are registered. <br /><br />In the US, a website-based supplier of medicines can check the authenticity of prescription, in India, it is not even possible to distinguish genuine from fake doctors. <br /><br /> The UK and the US have a drug regulator each, British Medicines and Healthcare products Regulatory Agency and US Food & Drug Administration, while in India, there are some 36 state-level drug controllers with powers to licence drug trade. <br /><br />In short, e-commerce in retail trade of medicines in India is fraught with unacceptable risks to patients and with no benefits to the nation. Why pursue the idea at all and for whose benefit?<br /><br /><em>(The writer is editor, Monthly Index of Medical Specialities)</em><br /></div>
<div><em>Sale of no goods online had stirred any controversy as that of medicines. With the law yet to be updated to govern online pharmacy, several e-tailers have jumped on to the pharmacy bandwagon. This has led to a huge outcry from the All India Organisation of Chemists and Druggists. Meanwhile, the government has set up a panel to go into the entire gamut of issues. </em><br /><br />Early this year, about 20 websites, including Amazon, Flipkart, Snapdeal and Shopclues, were found soliciting orders for online sale of drugs. More than 45 drugs were listed in one portal alone. <br /><br />Sensing violation of laws, the Maharashtra State Drug Controller raided the business premises of Snapdeal in Mumbai and seized “prescription only” brands like Ascoril of Glenmark (containing prescription-only ingredients like terbutaline or codeine, a derivative of narcotic morphine) and Vigora of German Remedies (containing sildenafil used in male impotence with some very serious and occasionally fatal side effects). <br /><br />Telangana also sought explanation from similar websites operating out of their jurisdiction. The sales were reportedly stopped.<br /><br />In the aftermath, the Drugs Consultative Committee, comprising state-level drug regulators, meeting on July 24 formed a seven-member sub-committee to “examine the issue of sale of drugs on the internet in the light of practices being followed in the developed countries.” <br /><br />Drugs Controller General of India (DCGI) Dr G N Singh reportedly stated that “online scenario may change,” thereby alluding to the possibility of legalising web-based sale of medicines. This infuriated the All India Organisation of Chemists and Druggists (AIOCD), and its 7.5 lakh members have now called for a nationwide strike on October 14.<br /><br />The drug regulation in India is bifurcated between Central Drugs Standard Control Organisation (CDSCO), headed by DCGI, and state-level drug authorities who function under their respective state governments and hence are not under CDSCO.<br /><br />In general, CDSCO has the power to approve new drugs, clinical trials and issue licences for blood products. State controllers are empowered to issue licences and monitor pharmaceutical producers, wholesale and retail traders. Thus, the sale of drugs lies exclusively within the purview of state controllers.<br /><br />At present, producers are allowed to sell drugs only to licensed dealers, registered doctors and hospitals. Retailers are licensed only if they have adequately equipped premises for storage of temperature-sensitive medicines and have qualified on-site pharmacists to dispense drugs against prescriptions by registered medical practitioners as well as advise patients about the right dosing schedule. <br /><br />The rules also permit sale of certain specified formulations from motor vehicles and specified simple remedies by general shops in villages with population less than 1,000 in the absence of a licensed drug retailer. <br /><br />However, there is no provision to deliver drugs to customers by mail or courier, which by their very nature lack appropriate storage conditions.<br /><br />Selling prescription drugs by persons other than pharmacists is a criminal offence that can land the offender in prison for six months as per the Pharmacy Act. It is obvious that many rules governing sale of drugs were being violated by portals and even by manufacturers or their authorised distributors.<br /><br />Flouting rules<br /><br />Drugs were supplied to websites not licensed by drug regulators. Stocks were kept at unauthorised premises not adequately equipped for temperature control. The possibility of medicines turning sub-standard could not be ruled out.<br /><br />Samples for quality and authenticity of drugs could not be collected routinely by state inspectors. The possibility of fake, counterfeit and sub-standard brands being dispensed could not be ruled out.<br /><br />Portals advertised prescription drugs to lay public in violation of Drugs and Magic Remedies Act which permits dissemination of information on drugs confidentially to only registered medical practitioners. <br /><br />Websites handed over drugs to unauthorised carriers, both postal and/or courier firms and portal’s own delivery staff that did not have facilities for temperature or moisture control during transit. Hence, the potency of such drugs could be compromised.<br /><br />Portals could not and did not check prescriptions by registered medical practitioners and did not endorse the same to comply with the law. Medicines were not dispensed by or under the supervision of pharmacists.<br /><br />Scrutinising doctors’ prescription by websites located outside the place of residence of patients is virtually impossible in India since every doctor needs to be registered by the state medical council of the area in which they practice. <br /><br />For example, if a doctor has obtained medical qualifications in Kerala and is registered by the Kerala Medical Council but in order to practice in Karnataka or Delhi, he needs to be registered again by the Karnataka/Delhi Medical Councils. <br /><br />How would a website located, say in Mumbai, check if (a) the scanned copy, even if obtained, is genuine and not tampered, (b) medical council registration corresponds to the place of residence of the patient and (c) how would the original prescription be endorsed as required by law for supplies made so that additional stocks are not obtained on the strength of the same prescription, more so in the case of psychotropic drugs such as anti-anxiety and anti-depressant which are not only misused for recreational purposes but can be fatal in over-dose.<br /><br />Temperature control is a tricky business. It is true that legally only some drugs, such as antibiotics, insulin, vaccines etc., need to be stored in refrigerators but manufacturers routinely advise that their formulations should be stored in “cool, dry place.” Others such as Ranbaxy go as far as to advise that its anti-asthma brand Synasma (doxofylline) should be “stored below 25 degree C.” The implication is that if the drug loses its potency due to higher temperature, then producer will not be legally liable.<br /><br />The websites were luring customers by offering a 10 per cent discount on MRP. But by not meeting stiff standards on premises and staff, expenses of websites are much lower coupled with larger discount from drug producers who also saved on the 30 per cent trade discount to distributors and retailers.<br /><br />Copying practices in e-commerce in pharmaceutical retail field from developed countries will harm patients due to different laws coupled with the federal structure in India. For instance, in Britain only the General Medical Council is responsible for registration of doctors, in India there are scores of state councils. <br /><br />In Britain, every registered doctor can practice anywhere, in India, s/he can only practice in the state where they are registered. <br /><br />In the US, a website-based supplier of medicines can check the authenticity of prescription, in India, it is not even possible to distinguish genuine from fake doctors. <br /><br /> The UK and the US have a drug regulator each, British Medicines and Healthcare products Regulatory Agency and US Food & Drug Administration, while in India, there are some 36 state-level drug controllers with powers to licence drug trade. <br /><br />In short, e-commerce in retail trade of medicines in India is fraught with unacceptable risks to patients and with no benefits to the nation. Why pursue the idea at all and for whose benefit?<br /><br /><em>(The writer is editor, Monthly Index of Medical Specialities)</em><br /></div>
