References
- DRAP bans brand names of medicines in doctors’ prescriptions. The Nation, 19th April 2021, https://nation.com.pk/19-Apr-2021/drap-bans-brand-names-of-medicines-in-doctors-prescriptions.
- DRAP directive to provinces: ‘Ensure doctors prescribed drugs with generic nams. The News, 19th April 2021. https://www.thenews.com.pk/print/822686-drap-directive-to-provinces-ensure-doctors-prescribed-drugs-with-generic-names.
- DRAP seeks opinion on generic medicines registration. 12th May 2021, https://www.thenews.com.pk/print/834047-drap-seeks-opinion-on-generic-medicines-registration.
- Babar ZU, Stewart J, Reddy S, Alzaher W, Vareed P, Yacoub N, Dhroptee B, Rew A. ‘An evaluation of consumers’ knowledge, perceptions and attitudes regarding generic medicines in Auckland. Pharm World Sci. 2010;32(4):440–448. https://doi.org/10.1007/s11096-.010-.9402-0.
- El-Dahiyat F, Kayyali R. Evaluating patients’ perceptions regarding generic medicines in Jordan. J Pharm Policy Prac. 2013;6(1):1–8.
- Hassali MA, Shafie AA, Jamshed S, Ibrahim MI, Awaisu A. Consumers’ views on generic medicines: a review of the literature. Int J Pharm Pract. 2009;17(2):79–88. (PMID:0214255).
- Jamshed SQ, Ibrahim MIM, Hassali MA, Masood I, Low BY, Shafie AA, Babar Z. Perception and attitude of general practitioners regarding generic medicines in Karachi, Pakistan: a questionnaire-based study. South Med Rev. 2012;5(1):22–30.
- El-Dahiyat F, Kayyali R, Bidgood P. Physicians’ perception of generic and electronic prescribing: a descriptive study from Jordan. J Pharm Policy Pract. 2014;7(1):7.
- Babar Z, Grover P, Stewart J, Hogg M, Short L, Seo HG, Rew A. ‘Evaluating pharmacists’ views, knowledge, and perception regarding generic medicines in New Zealand. Res Soc Admin Pharm. 2011;7(3):294–305.
- Din Babar Z, Awaisu A. Evaluating community pharmacists’ perceptions and practices on generic medicines: a pilot study from Peninsular Malaysia. J Generic Med. 2008;5(4):315–330.
- Kaplan WA, Ritz LS, Vitello M, Wirtz VJ. Policies to promote use of generic medicines in low- and middle-income countries: a review of published literature, 2000–2010. Health Policy. 2012;106(3):211–224. https://doi.org/10.1016/j.healthpol.2012.04.015.
- Hassali MA, Alrasheedy AA, McLachlan A, Nguyen TA, Al-Tamimi SK, Ibrahim MI, Aljadhey H. The experiences of implementing generic medicine policy in eight countries: a review and recommendations for a successful promotion of generic medicine use. Saudi Pharm J. 2014;22(6):491–503. https://doi.org/10.1016/j.jsps.2013.12.017.
- Tuleu C, Hughes DA, Clapham D, Vallet T, Ruiz F. Acceptability of generic versus innovator oral medicines: not only a matter of taste. Drug Discov Today. 2021;26(2):329–343. https://doi.org/10.1016/j.drudis.2020.11.008.
- Babar Z-U-D, Kan SW, Scahill SL. Interventions promoting the use of generic medicines: a narrative review of the literature. Health Policy. 2014. https://doi.org/10.1016/j.healthpol.2014.06.004.
- Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations. Center for Drug Evaluation and Research, Food and Drug Administration. Docket No. FDA-2014-D-0204, dated: 29th April 2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bioavailability-and-bioequivalence-studies-submitted-ndas-or-inds-general-considerations. Last accessed: 28th Nov 2022.
- Individual Product Bioequivalence Recommendations for Specific Products. Center for Drug Evaluation and Research, Food and Drug Administration. Docket No. FDA-2007-D-0433, dated 24th August 2018. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/individual-product-bioequivalence-recommendations-specific-products. Last accessed: 28th Nov 2022.
- Comparator products in Bioequivalence/Therapeutic Equivalence studies. Medicines and Healthcare Products Regulatory Agency Guidance, 31st Dec 2020. Available at: https://www.gov.uk/guidance/comparator-products-in-bioequivalencetherapeutic-equivalence-studies. Last accessed: 30th Nov 2022.
- Guideline on the investigation of bioequivalence. Committee for medicinal products for human use, European Medicines Agency. Doc Ref. No. CPMP/EWP/QWP/1401/98, 20th January 2020. Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf. Last accessed: 30th Nov 2022.
- British Pharmacopoeia. The Stationary Office, London. Available online at: https://www.pharmacopoeia.com/. Last accessed: 30th Nov 2022.
- European Pharmacopoeia (Ph. Eur.). European Directorate for the Quality of Medicines & Healthcare. Available online at: https://www.edqm.eu/en/european-pharmacopoeia. Last accessed: 30th Nov 2022
- The United Sates Pharmacopeia (USP) and the National Formulary (NF). The United States Pharmacopeial Convention. Available online at: https://www.uspnf.com/. Last accessed: 30th Nov 2022.
- Pakistan heart drugs: Lahore death toll reaches 100. BBC, 26th January 2012. https://www.bbc.co.uk/news/world-asia-16742832.
- Substandard (contaminated) paediatric medicines identified in WHO region of Africa. World Health Organisation, Medical Product Alert No. 6/2022, 5th October 2012. https://www.who.int/news/item/05-10-2022-medical-product-alert-n-6-2022-substandard-(contaminated)-paediatric-medicines.
- Cough syrup deaths: Why drugs made in India are sparking safety concerns. BBC, 17th October 2022. https://www.bbc.co.uk/news/world-asia-india-63226055.
- Indonesia bans all syrup medicines after death of 99 children. BBC, 20th October 2022. https://www.bbc.co.uk/news/world-asia-63324653.
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Center for Drug Evaluation and Research, Food and Drug Administration. Docket No. FDA-2013-S-0610, dated: 5th May 2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-ir-immediate-release-solid-oral-dosage-forms-scale-and-post-approval-changes-chemistry. Last accessed: 28th Nov 2022.
- SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation. Center for Drug Evaluation and Research, Food and Drug Administration. Docket No. FDA-1997-D-0380, dated: 5th May 2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-ss-nonsterile-semisolid-dosage-forms-scale-and-post-approval-changes-chemistry-manufacturing. Last accessed: 28th Nov 2022.
- SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. Center for Drug Evaluation and Research, Food and Drug Administration. Docket No. FDA-1997-D-0507, dated: 5th May 2020. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supac-mr-modified-release-solid-oral-dosage-forms-scale-and-postapproval-changes-chemistry. Last accessed: 28th Nov 2022.
- Babar ZUD. Ten recommendations to improve pharmacy practice in low and middle-income countries (LMICs). J of Pharm Policy and Pract. 2021;14:6. https://doi.org/10.1186/s40545-.020-.00288-2.
- UK executive accused in GlaxoSmithKline China probe. BBC News, 14th May 2014. https://www.bbc.co.uk/news/world-asia-china-27403914.
- GlaxoSmithKline ex-boss to be deported back to UK from China. The Guardian, 19th September 2014 https://www.theguardian.com/business/2014/sep/19/glaxosmithkline-china-mark-reilly-deported-uk-guilty-bribery-hunan.