Sunanda’s death and drug regulation
25 Jan 2014 11:43 PM GMT
On 17 January, Sunanda Pushkar, wife of the union minister Shashi Tharoor, was found dead in a hotel suite in Delhi. Autopsy findings indicated an overdose of a schedule H drug, Alprax; it is said that an overdose of Alprax may have resulted in a multi-organ failure, causing her death.
While details of her death are not completely clear, the possibility of yet another death due to an overdose of a prescription drug raises a simple question: why is drug regulation such a hassle in India?
The manufacture and sale of all drugs in the country is covered under the Drugs and Cosmetics Act and Rules. The most recent schedule H came out in 2006: it lists 536 drugs, with names ranging from Abacavir to Zuclopenthixol. These drugs cannot be purchased over the counter without the prescription of a qualified medical practitioner. Alprazolam, an ingredient of Alprax, belongs to a group of medicines called Benzodiazepines which is used to treat anxiety and panic attacks. In general, Benzodiazepines such as Alprax are to be consumed only for short periods (for example two to four weeks). A long-term use, unless advised by the doctor, can prove fatal. The government also has a schedule H1 to the Drugs and Cosmetics Act and Rules in order to curb the indiscriminate use of antibiotics, anti-tuberculosis and some other drugs in the country. There are 46 drugs under this restricted category. These drugs have a mandatory warning printed on them in a box with a red border on the label, and are sold by chemists only through prescription. The chemist retains a copy of the prescription and maintains a separate register for these 46 drugs where the name of the patient and the details of the doctor who prescribed the drugs are noted. This register is to be kept for three years after which they may be discarded.
The responsibility to enforce these orders rests with the central drugs standard control organisation (CDSCO). Violation of this provision by chemists can result in prosecution. State drug inspectors are entitled to conduct surprise inspections at the pharmacies and chemist shops to check the registers and sale of these schedule H1 drugs. While all the laws are in place, the real problem is the lack of their implementation. ‘One drug inspector is required for every 200 chemist shops but the availability is one drug inspector per 2000 shops,’ said Dr Jagdish Prasad, director general health services. ‘In the absence of optimum number of drug inspectors, it is difficult to ensure a proper drug regulatory mechanism.’
Health is a state subject, and the role of central government is confined to giving permission to the manufacturing of drugs. Whether the rules are followed or not is to be looked after by the drug inspectors appointed by the states. Unfortunately, even the states which otherwise perform better on public health indicators, falter here.
In Delhi, for example, out of the 31 sanctioned posts for drug inspectors, seven are currently lying vacant. According to sources, even though the rules for the recruitment of inspectors are being finalised as it has to be sent to the UPSC, the drugs control department in the capital is so severely under-staffed that proper regulation is virtually impossible.
‘Delhi has 17,000 retail and wholesale outlets, and as per the standard procedure, a minimum of 61 drug inspectors are required. We have only 24 drug inspectors right now,’ a senior officer of Delhi’s drugs control department said on condition of anonymity. ‘So how do you expect drug regulation to be effectively implemented?’
In addition, Dr D R Rai, senior vice-president, Indian medical association (IMA) said, ‘Government policy of putting the drugs under schedule H or H1 is good, but there is a total chaos at the implementation level. There are approximately 6 lakh chemist shops in the country but their regulation at the state level is not proper.’ Along with regulatory hurdles, another part of the problem is the fact that consumers don’t follow the simple rules while buying medicines: as high as 90 percent of the consumers in the country purchase medicines without bills; some even buy medicines through home delivery. The prescription rule is not properly implemented often because of a lack of regulation, but also because of the illiteracy, and therefore unawareness, of a majority of patients.
Poverty, it turns out, is the real culprit. A person advised to consume a drug that comes under schedule H1 will be allowed to buy it only after producing a prescription. Unfortunately, a majority of poor people, who can’t afford to buy medicines for the full course of the prescribed usage, buy them on a daily basis. The inability to complete the full course makes many patients suffering from illnesses like tuberculosis drug resistant.
On the other hand, if the prescription rule is strictly enforced, poor people wouldn’t be able to afford H1 drugs at all. The IMA, said Dr Rai, has proposed the ‘right to health’ to the government so that health can be made a fundamental right.
A unified policy on drug regulation is urgently required and this can only be done when we are able to pull out of the vicious circle of poverty and failure to effectively implement regulations.
By arrangement with Governance Now
While details of her death are not completely clear, the possibility of yet another death due to an overdose of a prescription drug raises a simple question: why is drug regulation such a hassle in India?
The manufacture and sale of all drugs in the country is covered under the Drugs and Cosmetics Act and Rules. The most recent schedule H came out in 2006: it lists 536 drugs, with names ranging from Abacavir to Zuclopenthixol. These drugs cannot be purchased over the counter without the prescription of a qualified medical practitioner. Alprazolam, an ingredient of Alprax, belongs to a group of medicines called Benzodiazepines which is used to treat anxiety and panic attacks. In general, Benzodiazepines such as Alprax are to be consumed only for short periods (for example two to four weeks). A long-term use, unless advised by the doctor, can prove fatal. The government also has a schedule H1 to the Drugs and Cosmetics Act and Rules in order to curb the indiscriminate use of antibiotics, anti-tuberculosis and some other drugs in the country. There are 46 drugs under this restricted category. These drugs have a mandatory warning printed on them in a box with a red border on the label, and are sold by chemists only through prescription. The chemist retains a copy of the prescription and maintains a separate register for these 46 drugs where the name of the patient and the details of the doctor who prescribed the drugs are noted. This register is to be kept for three years after which they may be discarded.
The responsibility to enforce these orders rests with the central drugs standard control organisation (CDSCO). Violation of this provision by chemists can result in prosecution. State drug inspectors are entitled to conduct surprise inspections at the pharmacies and chemist shops to check the registers and sale of these schedule H1 drugs. While all the laws are in place, the real problem is the lack of their implementation. ‘One drug inspector is required for every 200 chemist shops but the availability is one drug inspector per 2000 shops,’ said Dr Jagdish Prasad, director general health services. ‘In the absence of optimum number of drug inspectors, it is difficult to ensure a proper drug regulatory mechanism.’
Health is a state subject, and the role of central government is confined to giving permission to the manufacturing of drugs. Whether the rules are followed or not is to be looked after by the drug inspectors appointed by the states. Unfortunately, even the states which otherwise perform better on public health indicators, falter here.
In Delhi, for example, out of the 31 sanctioned posts for drug inspectors, seven are currently lying vacant. According to sources, even though the rules for the recruitment of inspectors are being finalised as it has to be sent to the UPSC, the drugs control department in the capital is so severely under-staffed that proper regulation is virtually impossible.
‘Delhi has 17,000 retail and wholesale outlets, and as per the standard procedure, a minimum of 61 drug inspectors are required. We have only 24 drug inspectors right now,’ a senior officer of Delhi’s drugs control department said on condition of anonymity. ‘So how do you expect drug regulation to be effectively implemented?’
In addition, Dr D R Rai, senior vice-president, Indian medical association (IMA) said, ‘Government policy of putting the drugs under schedule H or H1 is good, but there is a total chaos at the implementation level. There are approximately 6 lakh chemist shops in the country but their regulation at the state level is not proper.’ Along with regulatory hurdles, another part of the problem is the fact that consumers don’t follow the simple rules while buying medicines: as high as 90 percent of the consumers in the country purchase medicines without bills; some even buy medicines through home delivery. The prescription rule is not properly implemented often because of a lack of regulation, but also because of the illiteracy, and therefore unawareness, of a majority of patients.
Poverty, it turns out, is the real culprit. A person advised to consume a drug that comes under schedule H1 will be allowed to buy it only after producing a prescription. Unfortunately, a majority of poor people, who can’t afford to buy medicines for the full course of the prescribed usage, buy them on a daily basis. The inability to complete the full course makes many patients suffering from illnesses like tuberculosis drug resistant.
On the other hand, if the prescription rule is strictly enforced, poor people wouldn’t be able to afford H1 drugs at all. The IMA, said Dr Rai, has proposed the ‘right to health’ to the government so that health can be made a fundamental right.
A unified policy on drug regulation is urgently required and this can only be done when we are able to pull out of the vicious circle of poverty and failure to effectively implement regulations.
By arrangement with Governance Now
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