Generic drug prescription: Possible issues, impacts and consequences
When Bioequivalence studies are not necessary
i. When new drug are to be administered parenterally (e.g intravenous, intramuscular, subcutaneously, intrathecal administration etc.) as aqueous solution and contain the same active substance(s) in the same concentration and the same excipients in comparable concentrations;
ii. When the new drug is a solution for oral use, and contains the active ingredient in the same concentration, and does not contain an excipient that is known or suspected to affect gastro-intestinal transit or absorption of the active substance;
iii. When the new drug is a gas;
iv. When the new drug is a powder of reconstitution as a solution and the solution meets either criteria (a) or criterion (b) above;
v. When new drug is an otic or ophthalmic or topical product prepared as aqueous solution and contain the same active substance(s) in the same concentration(s) and essentially the same excipients in comparable concentrations;
vi.When new drug is an inhalational product or nasal spray, tested to be administered with or without essentially the same device as the reference product, prepared as aqueous solutions, and contain the same substance(s) in the same concentration and essentially the same excipients in comparable concentrations. Special in-vitro testing is required to document device performance comparison between reference inhalation product and the new drug product.
For the (v) and (vi) above, the applicant is expected to demonstrate that the excipients in the new drug are essentially the same and in comparable concentrations as those in the reference product. In the event this information about the reference product cannot be provided by the applicant, in vivo studies need to be performed.
Impact of prescribing generic drug on Indian Pharma trade:
i. Patient will gain attraction of availability of branded and generic drugs.
ii. Drug manufacturer and health care service provider relationship will be more transparent.
iii. Unethical prescription writing will come to an end.
iv. Cost of medication will be reduced.
v.New horizon for drug manufacturer.
vi. Accessibility of drugs to needy will improve regardless of their socio and economic factors.
vii. Present business model for most of the drug manufacturer will require reconsideration.
viii. Pharma-stocks will collapse.
ix. Pharma industry annual turnover will be affected.
x. Medical representative have to change their working model.
xi. A paradigm shift from doctors to pharmacist.
xii. Research and Development will be hampered.
xiii. Penning down Multivitamins and products with multiple drug combination will be tedious task for the doctor.
The generic drug can substantially reduce the cost involved in the treatment but the safety and efficacy shall not be compromised. The generic drug must prove to be bioequivalent with their branded counterparts. The possible and immediate impact of this decision will be that the unethical prescription by the doctors and the commission based prescription will be hampered. This decision will create new doors in the manufacturing of generic products, which in turn will impact the Research and Development of the New Chemical Entity (NCE). The Pharma drug manufactures have to change or modify their business model which in turn will impact the work force directly or indirectly involved with this sector. Ethical manufacturing, testing, marketing, selling and prescription should be the need of the hour with the utilization of trained and skilled (Pharmacy professionals) as Production Chemist, Drug analyst, Sales and Marketing executives and pharmacist for prescription handling.
1. Generic Drugs. http://www.who.int/trade/glossary/story034/en/index.html. (Accessed on 27-april-17).
2. What Are Generic Drugs? http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ ucm144456.htm. (Accessed on 27-april-17).
3. US-FDA: Guidance for Industry - Bioavailability and Bioequivalence. In FDA Guidance for Industry.
4. Process for Approving Generic Drugs. http://www.fda.gov/Training/ ForHealthProfessionals/ucm090215.htm. (Accessed on 27-April-17)
5. Guidelines for bioavailability and bioequivalence studies, central drug standard organization, directorate general of health services, ministry of health and family welfare, government of india, new delhi, (2005), page 3.
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