Pharma sector Current Affairs - 2019
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Union Health Ministry has released draft rules on sale of drugs by e-pharmacies to regulate online sale of medicines across India. These rules also have been proposed to ensure accessibility and availability of genuine drugs to the people across India from authentic online portals.
Key features of rules
It is mandatory for online pharmacies to register under Central Drugs Standard Control Organisation (CDSCO) and obtain trade licence applicable across India from any state government. E-pharmacies only need to take one licence in any state. They can sell drugs all over the country even if they have one licence.
E-pharmacies need to apply for grant of registration to Central Licensing Authority through online portal of Central Government. The registration issued to any person for e-pharmacy will remain valid for three years period from date of its issuance and renewal of registration will have to be done in case it wants to continue.
Registration of e-pharmacy can be suspended or cancelled if it contravenes any provision of the Drugs and Cosmetics Act, 1940. E-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000. It is mandatory for e-pharmacy to maintain keep details of patient confidential and not disclose it to any person other than Central Government or State Government concerned.
The supply of any drug shall be made against cash or credit memo generated through e-pharmacy portal and such memos shall be maintained by e-pharmacy registration holder as record. Sale of tranquillisers, psychotropic drugs, narcotics and habit forming drugs will be prohibited through these portals.
The premises from where e-pharmacy business is conducted will be inspected, every two years, by team of officers authorised by Central Licensing Authority, with or without experts in relevant field or officers authorised by the concerned State Licensing Authority.
It will be binding on e-pharmacies to deliver drugs in specific time that will be told to patient during time of purchase while the e-portals are mandatorily required to have 24/7 call centres. The e-pharmacy cannot advertise any drug on radio or television or internet or print or any other media for any purpose.
Indian Pharmacopoeia Commission (IPC) has in its 2018 edition of Indian Pharmacopoeia approved modern, animal-free tests for drug manufacturers. It will spare animals from suffering due to drug experiments.
2018 Indian Pharmacopoeia
It provides guidelines on tests for drugs manufactured and marketed in India. It replaces pyrogen test carried out on rabbits and abnormal toxicity test carried out on guinea pigs and mice with tests that can be done in test tubes. These guidelines will come into effect from July 1, 2018.
The pyrogen test will be replaced by bacterial endotoxin test or monocyte activation test which can be carried out in test tubes. For abnormal toxicity test, Vaccine manufacturers can apply for waiver by getting compliance certificate from National Control Laboratory.
People for the Ethical Treatment of Animals (PETA) India was pushing for doing away with cruel methods of testing on animals for the past several years. It had written to IPC in 2015 with several suggestions. These suggestions were discussed in a meeting of expert committee on vaccine standards that was held in 2016 and few of them have finally approved by IPC.
Pyrogen test is carried out to check impurity or substance that can cause adverse side-effects. For the test, drug is injected into rabbit and animal is closely observed for feverish symptoms. The abnormal toxicity test is carried out to check potential hazardous biological contamination in vaccine formulations. This batch test is done before product is approved for marketing. In this, mice or guinea pigs are injected with vaccine. The scientists observe if there is death of any animal.
Indian Pharmacopoeia Commission (IPC)
IPC is an autonomous institution of Ministry of Health and Family Welfare to set standards of drugs in country. Its basic function is to update regularly standards of drugs commonly required for treatment of diseases prevailing in the region. These set of standards are published under title Indian Pharmacopoeia (IP) similar to British Pharmacopoeia and United States Pharmacopeia. IPC publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in form of IP. It also promotes rational use of generic medicines by publishing National Formulary of India. IPC was established by executive orders in 1945 according to Indian Drugs and Cosmetics Act, 1940. It is headquartered in Ghaziabad, Uttar Pradesh.