A Proposal for new Quality attributes for Schedule R of the Indian Drugs and Cosmetics Act, 1940

  • Bayya Subba Rao Faculty


Original sin is not life but it is a part of life.  It establishes psychological, mental and physical health.  Statistics reveal several deaths of pregnant mothers, ectopic pregnancy, child deaths or original sin related diseases, apart from lethal consequences which is out of the scope of this article. Use of contraceptive methods may be beneficial in several circumstances avoiding unwanted pregnancies. A few television channels were scrolling the various contraceptive methods and educating the citizens for a good health perspective.  The objective of this review is not only to enlighten the various contraceptive methods but also in knowing their failure level methods and some unique evaluation methods that can be included in Schedule R of the Drugs and Cosmetics Act, 1940 so as to append the quality attributes with in-vitro and in-vivo original sin correlated models.  The review illustrates role of researchers/pharmacist/medical professionals in problem solving skills and is also expected to answer the general questions experienced and witnessed by the author relating to original sin including gender sensitization.  In India, several national level bodies also insist for academic accreditations the contributions relating to gender sensitization and the article meets criteria as well.  If the author as a common man sends a sample for current products for assessing abstract attributes, does Central Drugs Laboratory can?, a thought in this direction is needed which in turn indicates role of questionnaires/instruments in the Drugs and Cosmetics Act, 1940 and Rules 1945.  Does a need of a statutory warning for original sin products is necessary, a question is raised and a review by persons skilled in art is proposed.  The article illustrates either side to the context.  The article also helps to overcome barriers from society, professional point of view relating to original sin related research either at the pre-clinical or at the clinical levels.

Keywords: Contraception, failure indices, methods, evaluation, gender sensitization, health related quality of life, HRQOL, instruments


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1. Geneva. WHO Geneva, Contraceptive methods, Contraceptive Method Mix: Guidelines for Policy and Service Delivery, 1994 [Internet].Geneva: WHO; 1994 [cited 2020 Jul 8]. Available from:
2. John WM, Peter B, Nicola D, David C, Robin EO, Oliver H, Vicky LK, and Karl MR. Vaginal rings with exposed cores for sustained delivery of the HIV CCR5 inhibitor 5P12-RANTES. J Control Release [Internet]. 2019 [cited 2020 Nov 6]; 298:p. 1-11. Available from:
3. Van Kets H, Wildemeersch D, Van der Pas H, Vrijens M, Van Trappen Y, Delbarge W, Temmerman M, Batar I, Barri P, Martinex F, Wu Shangchun, Cao Xiaoming, Feng Zuan Chong, Wu Ming Hui, Pizarro E, Andrade A and Thiery M. IUD expulsion solved with implant technology, Contraception. 1995; 51:87-92.
4. Sujuan Gu, Irving Sivin, Mingkun Du, Linde Zhang, Lirong Ying, Fan Meng, Songling Wu, Peizhu Wang, Yunli Gao, Xin He, Lifang Qi, Changrong Chen, Yiping Liu and Dan Wang. Effectiveness of Norplant Implants Through Seven Years: A Large Scale Study in China, Contraception. 1995; 52:99-103.
5. Diaz S, Schiappacasse V, Pavez M, Zepeda A, Moo Young AJ, Brandeis A, Lahteenmaki P, Croxatto HB. Clinical Trial with Nestorone Sub dermal Contraceptive Implants, Contraception. 1995; 51:33-38.
6. Kattering J. Efficacy of thermoplastic elastomer and latex condoms as viral barriers, Contraception. 1993; 47(6):559-567.
7. CDSCO, Government of India, Ministry of Health and Family Welfare, The Drugs and Cosmetics Act-1940 and Rules-1945 as amended up to the 31st December, 2016 [Internet]. India: CDSCO; 2016 Dec 31 [cited 2020 Jun 29]. Available from:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmetics Act1940Rules1945.pdf
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How to Cite
Rao, B. S. “A Proposal for New Quality Attributes for Schedule R of the Indian Drugs and Cosmetics Act, 1940”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 1, Mar. 2021, pp. 10-14, doi:10.22270/ijdra.v9i1.449.