The Status of Pharma Sector Reviewed in Parliament
New Delhi: The Rajya Sabha has taken cognisance of risks prevailing due to the exiting drug irregularities, on the consumer market of the country. Discussing in detail sale of spurious drugs, online sale of medicines and an assessment of the impact arising out of custom duty hike, Health Minister Mr. JP Nadda informed members of parliament with the line of action taken so far by his ministry to maintain checks and balances on suspected and confirmed irregularities prevailing in the pharma industry.
Talking about the spurious drug racket, the Minister Health informed the parliament that over 47,000 drug samples had been picked up in a nation-wide survey in 2015, by the Ministry of Health and Family Welfare to determine the extent of Spurious/Not of Standard Quality drugs in the country. He however accepted that the results had yet to be compiled for the same.
Talking about the measures taken so far to ensure quality maintenance of drugs the Minister spoke about stringent penalties & offences being made cognizable as well as non-bailable;establishing of special designate Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal of cases; announcement of a ‘Whistle Blower Scheme’ to encourage vigilant public participation; issuance of guidelines to the State Drugs Controllers for taking action on samples of drugs declared spurious or not of standard quality; and instructions to the concerned staff to keep a vigil and draw samples of drugs for test and analysis for monitoring the quality of drugs.
Talking about action taken against offenders selling spurious drugs in the past Mr. Nadda said action / prosecution was launched as per the provisions of the Drugs and Cosmetics Act, 1940. To further substantiate the Minister informed that based on samples drawn, tested / analysed by drug regulatory officials of the Centre / State, the extent of adulterated/spurious drugs was 0.27, 0.11, 0.16 and 0.11 percent for 2011-12, 2012-13, 2013-14 and 2014-15 respectively.
Coming to the point of online sale of drugs in the country The Minister said all sale of drugs was regulated by State Licensing Authorities. As per the Drugs and Cosmetics Rules, 1945, drugs specified in Schedule H, H1 or Schedule X cannot be sold except on and in accordance with the prescription of a Registered Medical Practitioner. He emphasised that all prescription drugs could only be sold under the personal supervision of a registered pharmacist from a licensed premises.
He further stated that besides appointing a sub committee to examine the issue of sale of drugs on internet,the Drug Controller General (India) had in a a letter dated 30.12.2015 has alerted all State/UT Drug Controllers to put a strict vigil on the on-line sale of medicine and take action against those violating the Drugs and Cosmetics Act and Rules.
Discussing the impact on Impact on Healthcare of Customs Duty Hikes, Health Minister, Mr. J.P. Nadda announced that prices of drugs which came under the National List of essential Medicines (NLEM) were linked to the increase/decrease in the Wholesale Price Index (WPI) in terms of Drugs Price Control Order, 2013. Drugs on which custom duty exemption was granted were those that were included in the NLEM, 2015 the Minister Health added.
Minister Health also made clear that in the likelihood of a declining WPI this year, the price of drugs were also likely to fall. According to Mr. Nadda in respect of non-scheduled drugs, the annual increase in the Maximum Retail Price (MRP) could not be raised beyond 10%.
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Spurious Drug Racket
Talking about the spurious drug racket, the Minister Health informed the parliament that over 47,000 drug samples had been picked up in a nation-wide survey in 2015, by the Ministry of Health and Family Welfare to determine the extent of Spurious/Not of Standard Quality drugs in the country. He however accepted that the results had yet to be compiled for the same.
Talking about the measures taken so far to ensure quality maintenance of drugs the Minister spoke about stringent penalties & offences being made cognizable as well as non-bailable;establishing of special designate Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal of cases; announcement of a ‘Whistle Blower Scheme’ to encourage vigilant public participation; issuance of guidelines to the State Drugs Controllers for taking action on samples of drugs declared spurious or not of standard quality; and instructions to the concerned staff to keep a vigil and draw samples of drugs for test and analysis for monitoring the quality of drugs.
Talking about action taken against offenders selling spurious drugs in the past Mr. Nadda said action / prosecution was launched as per the provisions of the Drugs and Cosmetics Act, 1940. To further substantiate the Minister informed that based on samples drawn, tested / analysed by drug regulatory officials of the Centre / State, the extent of adulterated/spurious drugs was 0.27, 0.11, 0.16 and 0.11 percent for 2011-12, 2012-13, 2013-14 and 2014-15 respectively.
Online Sale of Drugs
Coming to the point of online sale of drugs in the country The Minister said all sale of drugs was regulated by State Licensing Authorities. As per the Drugs and Cosmetics Rules, 1945, drugs specified in Schedule H, H1 or Schedule X cannot be sold except on and in accordance with the prescription of a Registered Medical Practitioner. He emphasised that all prescription drugs could only be sold under the personal supervision of a registered pharmacist from a licensed premises.
He further stated that besides appointing a sub committee to examine the issue of sale of drugs on internet,the Drug Controller General (India) had in a a letter dated 30.12.2015 has alerted all State/UT Drug Controllers to put a strict vigil on the on-line sale of medicine and take action against those violating the Drugs and Cosmetics Act and Rules.
Custom Duty Hike
Discussing the impact on Impact on Healthcare of Customs Duty Hikes, Health Minister, Mr. J.P. Nadda announced that prices of drugs which came under the National List of essential Medicines (NLEM) were linked to the increase/decrease in the Wholesale Price Index (WPI) in terms of Drugs Price Control Order, 2013. Drugs on which custom duty exemption was granted were those that were included in the NLEM, 2015 the Minister Health added.
Minister Health also made clear that in the likelihood of a declining WPI this year, the price of drugs were also likely to fall. According to Mr. Nadda in respect of non-scheduled drugs, the annual increase in the Maximum Retail Price (MRP) could not be raised beyond 10%.
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