ONLINE MEDICINE DELIVERY COMPANIES - LEGAL POSITION IN INDIA
The
Drugs and Cosmetics Act, 1940 is the operation of administer the drugs and
cosmetics that is handling under the policy of government with the help of
amendments, conventions, acts and with described strategies. The rise of drug
and cosmetics or pharmaceutical products has been risen up fortunately day
after day. There are so many acts and committees have been set upon to
distinguish what is right or wrong or in what sense the pharmacy industry
grows. The whole structure of the mentioned industry carries out by acts such
as Drugs and Cosmetic Regulation Act, 1940, Drugs and Cosmetic Regulation
Rules, 1954, which regulates the sale, manufacture or distribution of the drugs.
- Information Technology Act, 2005, emphasizes the electronic platforms.
- Pharmacy
Practice Regulation Act, 2015, considers more upon the modes and
classifications of
the rules given under upon the e-pharmacy.
- Indian Medical Act, 1956 matters on the way of dispense of medicines on both the platforms .i.e. online and offline modes, etc. and taking into considerations the conventions and committees involves such as the four amendments made upon the-
- Narcotic Drugs and Psychotropic Substance Act, 1985,
- Indian Internet Pharmacy Association (IIPA), Federation of Indian Chambers of Commerce & Industries (FICCI),
- Indian Pharmaceutical Alliance (IPA)
- Indian Medical Association (IMA) etc.
Therefore, the sum up of these committees and acts visualizes the platform and enlarging with the precautions they have to take, the measures they must provide to the authorities by giving them opportunities to propose their way of manner in which they have to socialize but keeping in mind- the health, wealth, humanity, surrounding, atmosphere, situations etc.
CLASSIFIED DRUGS AND COSMETICS: MISBRANDED AND ADULTERATON
The Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 expands and divides the variance of drugs and cosmetics through the rules and regulations, observations and proposals made within the government.The misbranded and adulteration drugs and cosmetics, specifically mentioned in the act and called as which are not being labeled and contains harmful substances respectively.
THE PURE FOOD AND DRUG ACT, 1906:
The Pure Food and Drug Act, 1906, regulated the difference between misbranded and adulterated drugs, concerned with the purity and safety level but due to the surrounding of unprotected claim and unsafe areas or the complaints come upon the act or evolving cases, the act had been prohibited as it did not differentiated the list of labels of use of ingredients, taking precautions and giving proposals. Thus, the new Food, Drug and Cosmetic Act, 1938 has been amended for taking such further precautions. Therefore, it plays a big role before the e-pharmacy and after the e-pharmacy:
a. Prior to the E-Pharmacy:
Before
any of the distribution has made, there must be a look upon such safety and
quality measures of such drugs as pharmacists should have taken the
responsibilities of their reputation. They must define a need of such
prescribed medicines. Though before the e-pharmacy also, many of the
pharmacists have also even violated the laws through many a ways due to the
weak implementation of the prescribed act. After this prohibited act, the
functionaries of the pharmacists have been going into the positive direction,
thus, the new agency the FDA, 1938, strengths the quality of drugs and called
as a “new drug policy”. The Act may exert a direct influence upon such
pharmacists and therefore, creates a restrictive environment.
b. After the E-Pharmacy:
Now, as the FDA Act had been amended or transformed into the FDC Act, the industry has been now more restrictive and qualified as their implementation is more restraint. Given the more open areas to industries to grow with the layers of electronic transmission, so, somewhere we may say it widens the pharmacy and might be destroying the lives of an individual. As through the time of FDA, the act also implemented penalty provisions regarding violations of such particular drug products. Now, also the punishment of violation of provisions are there but the way is, “larger the platform, smaller will be our visualization” that has been happening to the platform of e-pharmacy.
DURHAM-HUMPHREY AMENDMENT:
However, an amendment was enacted in 1951 called as Durham-Humphrey Amendment, which authorizes with the legal binding medications to all licensee mentioned pharmacists, for regulate the products. After the pharmacy industry has been generated into e-pharmacy industry, there would have the smooth revolutionaries, greater power upon the drugs and new technologies emerged. The emphasis emerges by the pharmacy upon to the online delivery medications as a result of delivery of medications even without the prescriptions as a result of which drugs such as misbranded and adulterated usage increases even with the authorization of rules and regulations.
INFORMATION TECHNOLOGY ACT, 2000:
Section 4 of the Act: Legal recognition of electronic records.-Where any law provides that information or any other matter shall be in writing or in the typewritten or printed form, then, notwithstanding anything contained in such law, such requirement shall be deemed to have been satisfied if such information or matter is-
Rendered or made available in an electronic form; and
Accessible so as to be usable for a subsequent reference[1].
Section 5 of the Act: Legal
recognition of [electronic signature]. -Where any law
provides that information or any other matter shall be authenticated by
affixing the signature or any document shall be signed or bear the signature of
any person, then, notwithstanding anything contained in such law, such
requirement shall be deemed to have been satisfied, if such information or
matter is authenticated by means of [electronic signature]
affixed in such manner as may be prescribed by the Central Government[2].
Therefore, classifies the electronic medium by providing such electronic records to the e-pharmacy taking charge of all electronic forms or records which all are providing by affixing the signatures upon the documents and taking all signs upon all the rules and regulation binding as such.
As a matter of Agonize:
Despite of all these, there has been continuously misuse of prescription that are moving in the online platform. There is a big risk of being taking medicines of a particular disease by showing same and same prescription again and again through different pharmacies and might receive a big loss by taking multiple times any of a particular medicine.
The policies of drug has come under the Schedule 7 of State list of our constitution and thus, regulated by the state authorities. The online pharmacies may be an opt to the consumers who do not have such state restrictions for any of the medicines, but might get from another as the online pharmacies have the policies in all over the country.
PROS AND CONS OF THE ONLINE DELIVERING PHARMACIES:
PROS:
1.
Modern
Modernization Act, 2003
According to the Modern Modernization Act (MMA) 2003, online pharmacy has increases the health care departments by improving and reducing medication stress upon the limited medication services. The United States Health Department (USHD), e-pharmacy, have reduced pharmacists inaccuracy by expanding the industry in the country whether offline or online.
The Health Insurance Portability and Accountability Act, 1996
The
Health Insurance Portability and Accountability Act of 1996 (HIPAA) is the most
significant piece of federal legislation to affect pharmacy practice since
OBRA-90[3].
The HIPAA have more stringent rules, regulations and privacy policies to
protect the rights of patients such as the right to information and policies of
such online pharmacists, right to access their information and right to seek information
of procedures they have carried and right to protect the information as
confidential of the patients.
CONS:
Nationwide Strike:
All India Organization of Chemists & Druggists (AIOCD), directed a nationwide strike that had been preformed against the online pharmacies resolution and stated that it might be difficult for us or the country to substantiate the standard, classification and quality of the online selling medicines.
Storage and Transportation Condition:
- However, the main concern goes towards the storage and transportation conditions. There may be the conditions or circumstances of misappropriation, less strength or mortification of the medicines which requires storage conditions for example there are many medications upon which clearly stated that kept it in a cool and dry place.
- Misappropriation may also easily be happen as we cannot identify each and every face of pharmacist, as this is a huge industry.
- There has also been many concern arises as to the counseling, due care and the variance of medicines such as advantages and disadvantages which a patient can do easily in front of any pharmacist but how could be online?
[1] Information Technology Act, 2005
[2] Information Technology Act, 2005
[3] https://www.expresspharma.in/cover-story/e-pharmacies-waging-a-battle-for-survival/
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