The introduction of the National Medicines Regulatory Authority Act No. 05 of 2015 (Now referred to as the ‘NMRA Act’), aimed at protecting consumers from being exposed to spurious medicinal products in the market, would in effect open floodgates for counterfeit products in the Sri Lankan market in so far as such products relate to Cosmetics.
A plain reading of Section 146 of the NRMA Act brings out the factual position of the cover provided through this section for ‘cosmetics’ with a medicinal element.
In other words, if one could categorise a cosmetic as not coming under the consideration of a medicinal element, such cosmetic under the new law need not be registered under the new NMRA Act and could be freely available in the market and in all probability, a sub standard product.
When one compares this position with the now repealed Cosmetics, Devices and Drugs Act No. 27 of 1980 (CDD Act), Cosmetics under the CDD Act had a wide scope and in essence prevented counterfeit/sub standard cosmetic products entering the market.
The de-regulation of the CDD Act has created a situation where there is no level playing field for cosmetics.
However, prudent and opportune the intention of the enactment of the new NMRA Act would have been, one cannot hide under the fact that the definition given to cosmetics in section 146 of the Act is restrictive, narrow in scope and encompasses a huge danger and risk for the consumers/customers of this country.
The inclusion of Cosmetics under ‘borderline products’ has given rise to unforeseen complications.
Firstly ‘borderline products’ is a transitional term used prior to determining whether a product would be categorised as medicinal or Cosmetic.
Therefore, the definition given in the Act for borderline products and cosmetics itself causes confusion and is rest assured to run into a plethora of practical difficulties in the implementation process.
“Borderline Products” is essentially a classification given birth to by the European Union and needs to be cautiously considered, when adopting to the Asian region. In fact the classification of ‘Borderline Products”, only exists until the relevant regulatory authority examines and determines, which category of product the said ‘borderline products’ would fall into i.e. cosmetics or medicine.
Essentially, the word borderline comes into play depending on the manner in which the manufacturer/marketer presents a particular item to the public. It is at that stage that the NMRA Act should decide whether such product becomes medicinal or is a cosmetic. Therefore, there can be no new categorisation called ‘borderline products’.
"Firstly ‘borderline products’ is a transitional term used prior to determining whether a product would be categorised as medicinal or cosmetic. Therefore, the definition given in the Act for borderline products and cosmetics itself causes confusion and is rest assured to run into a plethora of practical difficulties in the implementation process. "
The stark reality is that the new legislation has not comprehensively dealt with the references made to in the CDD Act with regards Cosmetics.
The only way out of this unforeseen predicament is to pass appropriate legislation to define cosmetics ‘proper’.
This should essentially be done through appropriate amendment to the Act in the interest of the consumers and public at large. A re- introduction of the provisions that existed in relation to Cosmetic products in the CDD Act seems to be the plausible option.
Another alarming factor is the non- inclusion of empowering provisions for the NMRA to approve cosmetics and as at present leaves a carte blanche for spurious and substandard cosmetic products to be introduced to the market.
Many experts in the field are of the view that the moving out of the CDD Act should have been phased out systematically, which in effect would have minimised the threshold matters referred to in this article.
The need of the hour therefore, is to reconsider the existing provisions of Chapter V of the NMRA Act with regards cosmetics and to amend the Act and define cosmetics without any ambiguity separating cosmetic products with a medicinal element so that cosmetics in their entirety would be regulated to create a level playing field for all players in the market.
Comments - 0
Comments will be edited (grammar, spelling and slang) and authorized at the discretion of Daily Mirror online. The website also has the right not to publish selected comments.