 bill  no  311 of  2016 the drugs and cosmetics (amendment)  bill, 2016 by shri raghav lakhanpal,  mp a bill further to amend the drugs and cosmetics act, 1940be it enacted by parliament in the sixty-seventh year of the republic of india as follows:—1 (1) this act may be called the drugs and cosmetics (amendment) act, 2016short title and commencement(2) it shall come into force on such date as the central government may, by notification in the official gazette, appoint52 in  section 5 of the drugs and cosmetics act, 1940,—| 23 of 1940   ||---------------|| of section 5 |(a) in sub-section (2), after clause (xvi), the following clause shall be inserted, namely:—"(xvii) one scientist who shall be an expert in non-animal alternatives, to be nominated by the central government"; and10(b) in sub-section (3), in proviso, for the words "or clause (xvi)", the words "or clause (xvi) or clause (xvii)" shall be substituted statement of objects and reasonsin 2007, the national academy of sciences in the united states identified the need for a fundamental paradigm shift in the way safety testing is carried out, envisioning" a not-so-distant future in which virtually all routine toxicity testing would be conducted in human cells or cell lines" the approach - termed "toxicology from the 21st century" or "tox 21" - involves uncovering exactly how chemicals disrupt normal human biological processes at the molecular and cellular levels, and then using state-of-the-art in vitro, computational, and robotic tools to test for these disruptions and make predictions regarding real-world risks to peoplesome of the new technology being developed is truly revolutionary harvard university's wyss institute is developing an approach known as "organs-on-a-chip" in which human cell cultures are subjected to dynamic forces (eg lung cells "breathe") and subsequently display properties that are very similar to those seen in vivo in humanshowever, very little of it is seen in india, whether in research or in regulation while the ministry of health and family welfare, government of india has made landmark decisions of prohibiting animal testing for cosmetics and phasing out the infamous draize test, there is a lack of scientific expertise available on key committees to relay the progress made in research regulationindia has been signatory to the mutual acceptance of data (mad) agreement of the organisation for economic co-operation and development (oecd) since 2011 the oecd contains a number of non-animal alternatives for any of its member countries or mad signatory countries to uptake however with india, the consideration of uptake of these alternatives have been close to nil with the advent of alternatives in a larger way in the near future owing to the development of alternatives worldwide and the requirements of indian law, ie, section 17(2)(d) of chapter iv of the prevention of cruelty to animals (pca) act,1960 requires that "experiments on animals are avoided wherever it is possible to do so", it is important that a scientist with knowledge and expertise on non-animal alternatives to experimentation is included in the drugs technical advisory board under the drugs and cosmetics act, 1940 so that redundant animal testing could be avoided wherever necessaryhence this billnew delhi;raghav  lakhanpalnovember 16, 2016 annexure extract from the drugs and cosmetics act, 1940 act no 23 of 1940the drugs technical advisory board5 (1) the central government shall, as soon as may be, constitute a board (to be called the drugs technical advisory board) to advise the central government and the state governments on technical matters arising out of the administration of this act and to carry out the other functions assigned to it by this act(2) the board shall consist of the following members, namely:—(xvi) two persons holding the appointment of government analyst under this act, to be nominated by the central government (3) the nominated and elected members of the board shall hold office for three years, but shall be eligible for renomination and re-election:provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the board———— a billfurther to amend the drugs and cosmetics act, 1940————(shri raghav lakhanpal, mp)