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Telemedicine

Telemedicine a term framed in the 1970s, which literally means “healing at a distance”. It signifies the use of information communication technology (ICT) to improve patient outcomes by increasing access to care and medical information.

According to WHO telemedicine is defined as “the delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”.

Elements related to telemedicine

Reference-

apps.who.int/medicinedocs/documents/s21608en/s21608en.pdf

 

  • Telemedicine is the use of medical information exchanged from one treatment site to another via electronic communications.
  • It provides clinical support in order to improve health outcomes.
  • It overcomes geographical barriers, connecting users who are not in the same physical location such as from rural and remote areas.
  • It involves the use of various types of ICTs.
  • It is useful in emergency and critical care situations where moving a patient may be undesirable and/ or not feasible.
  • It facilitates patients and rural practitioners’ access to specialist health services and support.
  • It lessens the inconvenience and/or cost of patients transfers.
  • It comprises videoconferencing, transmission of still medical images, document sharing, remote monitoring of vital signs.

Essential Medicines

Essential medicines are those that satisfy the priority health care needs of the population.

These medicines are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.

The essential medicines concept states that a limited number of carefully selected essential medicines, with proven efficacy, safety and quality, leads to better health care, better management of medicines and lower health care costs for the majority of the population with common diseases.

Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.

Ministry of Health & Family Welfare (MOHFW), Government of India is mandated to ensure the quality healthcare system by assuring availability of safe and efficacious medicines for its population.

The Central Drugs Standard Control Organization (CDSCO), MOHFW, Government of India works as the Central Drug Authority of India for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. The first National List of Essential Medicines (NLEM) of India was prepared and released in 1996.This list was subsequently revised in 2003,2011 and 2015.

Salient features of NLEM 2015: –

  • For essentiality of requirement the medicines have been categorized as follows: - P, S and T denote essentiality at Primary, Secondary and Tertiary levels.
  • There were 348 medicines listed in NLEM 2011. A total of 106 medicines have been added, and 70 medicines have been deleted to prepare NLEM 2015 which now contains a total of 376 medicines.
  • There are 209 medicine formulations listed for all levels of health care (P, S, T), 115 medicine formulations for secondary and tertiary levels (S, T) and 79 medicine formulations for the tertiary level (T). (It is to be noted that formulations of certain medicines are listed at different levels but as item, they are counted as one. The total number of medicines remains 376).

National lists of essential medicines (NLEM) India-2015 can be seen by clicking at 

cdsco.nic.in/writereaddata/nlem-2015/nlem,%202015.pdf

References-

apps.who.int/medicinedocs/pdf/s6171e/s6171e.pdf

cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Consumer_Section_PDFs/Essential_meds.pdf

 

Banned Drugs

Drugs undergo rigorous testing before they are introduced into the market. They are first tested in animals and then in human beings during clinical trials.  The efficacy as well as safety profiles of the drug are tested.   In spite of this, some adverse effects of drugs appear only after the drug is used in the general population.  These adverse effects are detected though a process of regular monitoring after the drug is released called pharmacovigilance. 

If the adverse effects are severe or if the drug is ineffective, the country may ban the drug. Some drugs may have adverse effects only when combined with particular drugs.  In such cases, only the fixed dose combination is banned and not the individual drugs. A number of individual drugs as well as fixed dose combinations are banned in India.
 

List of drugs prohibited for manufacture and sale through gazette notification under section 26 A of Drugs & Cosmetics Act 1940 by the Ministry of Health and Family Welfare released on 1st January 2018  can be seen at -https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTY4Mg==

 

National Formulary of India (NFI)

What is a formulary?

Formulary is a manual containing clinically oriented summaries of pharmacological information about selected drugs. The manual may also include administrative and regulatory information pertaining to the prescribing and dispensing of drugs. A national formulary generally concentrates on available and affordable medicines that are relevant to the treatment of diseases in a particular country. Formularies are also frequently created for different levels of health care, different sectors and for individual hospitals.

The first, second and third editions of National Formulary of India (NFI) were published in 1960, 1966 and 1979 respectively by the Ministry of Health, Government of India. In the past 3 decades there has been vast expansion in the range of new drugs and their formulations. To address the need of publication of an updated version of NFI, Ministry of Health and Family Welfare, Govt. of India assigned this mandatory responsibility to the Indian Pharmacopoeia Commission (IPC), Ghaziabad and hence the NFI is being published by the IPC on the behalf of Ministry of Health and Family Welfare, Govt. of India. This National Formulary has been adopted from the WHO Model Formulary and thoroughly updated for its content, especially keeping in view the end user in India.

To support the health care professional and other stakeholders on rational use of medicines and to full fill the mandate of the Indian Pharmacopoeia Commission, the 5th edition of NFI-2016 was published with 521 number of drugs monographs.

NFI 4th Edition 2011 can be seen at http://www.cdsco.nic.in/writereaddata/NFI_2011%20(1).pdf

5th Edition of NFI 2016- https://nabh.co/Announcement/National%20Formulary%20of%20India%20(NFI)%202016.pdf

References-

www.who.int/medicines/services/essmedicines_def/en/

/apps.who.int/medicinedocs/en/m/abstract/Js23089en/

 

The Drugs and Cosmetics Act and Rules

The Parliament of India formed an Act which regulates the import, manufacture and distribution of drugs in India. The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards. The Drugs Act was formulated in 1940 in pursuance of recommendations of Chopra Committee constituted in 1930 by Government of India.  The drugs under the Drugs and Cosmetic Act cover wide varieties of therapeutic substances, diagnostics and medical devices.

Under the Act cosmetic means any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced in to, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting the attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic but does not include soap. The Act has been further amended as Drugs (amendment) Act 1964 (13 of 1964) to include Ayurvedic and Unani drugs.

The Drugs Act, as enacted in1940, has since been amended several times and is now titled as “The Drugs and Cosmetics Act, 1940”.

The drug rules were promulgated in December 1945 and enforcement of these rules started in 1947. The Rules have also been amended time to time to meet the needs of the time and to rectify any deficiencies noticed during the implementation.

The responsibility of enforcing the various Acts vests with the Central government and State/Union Territory (UT) governments. Under the Drugs and Cosmetics Act, the drugs are classified in schedules and regulations are laid down for their storage, display, sale, dispensing, leveling, prescribing etc.

Know details about Drugs and Cosmetics Act, 1940 and Rules,1945 As amended up to the 31st December 2016-cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf

References-

cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf

 

Central Drugs Standard Control Organization (CDSCO)

The Central Drugs Standard Control Organization (CDSCO) is the central drug authority established for discharging functions assigned to the central government under the Drugs and Cosmetics Act. It works under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO has six zonal offices, four sub zonal offices, thirteen port offices and seven laboratories across the country.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of new drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring uniformity in the enforcement of the Drugs and Cosmetics Act.

To know more about CDSCO –Click Here

Reference-

cdsco.gov.in/opencms/opencms/en/Home/

 

Pharmacovigilance

Pharmacovigilance is defined as the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The ultimate goal of this activity is to improve the safe and rational use of medicines, thereby improving patient care and public health.

Adverse Drug Reactions (ADR) or adverse reaction is defined as a response to a medicine used in humans or animals, which is noxious and unintended, including lack of efficacy, and which occurs at any dosage and can also result from overdose, misuse or abuse of a medicine.

References

/www.cdsco.nic.in/writereaddata/pharmacovigilanceGuidance.pdf

 

Clinical trials

For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes phase 1 to phase IV trials. 

New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E)- MARCH 19, 2019/ can be seen at

cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ==

Reference-

/www.who.int/ictrp/faq/en/

 

Pharma Jan Samadhan

The Pharma Jan Samadhan (PJS) initiative is part of Goverment of India's Digital India initiative, which aims at empowering the citizen through a transparent, accountable and responsive governance system.

The PJS provides the consumer with an effective and time bound grievance redressal system to effectively deal with complaints related to pricing, shortage and non-availability of medicines. Apart from the internet- based online facility, there is a consumer Help Line also, which can be used to lodge complaints.  Complaints may also be sent to:

Member Secretary,
NPPA, 3rd Floor, YMCA Cultural Centre Building,
1, Jai Singh Road, New Delhi – 110 001.
Tel: 011 – 23746649
Fax: 011 – 23746652
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Help Line no. : 011 – 23746647

User Manual for Pharma Jan Samadhan

Register your complain

Search for medicine prize fixed by National Pharmaceutical Pricing Authority-Click here

Reference-

www.nppaindia.nic.in/en/homelinks/pharma-jan-samadhan/

 

 

Dos and Don’ts for the consumers

DO’S

  • Buy medicines only on the prescription of your doctor.
  • Buy all medicines from a licensed chemist only and insist on a cash memo while purchasing the same
  • Retain the cash memo till you consume the medicines. lt may be useful in case of investigation of adverse reaction or other complaint.
  • Consult your doctor promptly in case any reaction or lack of efficacy of medicine persists.
  • Always check the medicines for their:
  • Name
  • Expiry date
  • Price on the label
  • Right quantity
  • Ensure that the seal is intact
  • Always store medicines at your house in proper places away from moisture and direct sunlight.
  • Do take each medication exactly as it has been prescribed.
  • Do make sure that all your doctors know about all your medications.
  • Do let your doctors know about any other over-the-counter medications, vitamins and supplements, or herbs that you use.
  • Do try to use the same pharmacy to fill all your prescriptions, so that they can help you keep track of everything you're taking.
  • Do keep medications out of the reach of children and pets.

 

DON’TS

  • Don’t pay more than the maximum retail price on the label of medicine.
  • Don’t purchase/consume the medicine, of it has crossed expiry date.
  • Don't change your medication dose or schedule without talking with your doctor.
  • Don't use medication prescribed for someone else.
  • Don't crush or break pills unless your doctor instructs you to do so.
  • Don't use medication that has passed its expiration date.
  • Don’t store your medications in locations that are humid, too hot or too cold. For example, the bathroom cabinet may not be the best place for your medication