Amendments to NMRA Act to give more teeth to regulate cosmetics

• Currently only imports monitored via entry points
• Amendments to also revise punishments given for offences under NMRA Act
• MRP on drugs saves patients over Rs. 9 b in the last two years

The National Medicines Regulatory Authority Act is set to gain wider purview to regulate cosmetic products in the market and revise penalties outlined in the legislation.

The cosmetics regulatory function, which was earlier handled by the Cosmetics, Devices, and Drug Regulatory Authority (CDDRA), was removed from the NMRA Act, which replaced the earlier entity. However a revision of the Act, which is now with the Legal Draftsman, will ensure that the entity will be given wide powers to regulate the cosmetic industry.

“The regulations will come with the amendments to the Act which is being drafted now,” NMRA Chief Executive Officer (CEO) Dr. Kamal Jayasinghe told Daily FT.

Currently, the NMRA monitors imported cosmetics only at the point of entry, after Cabinet decided a year ago that monitoring should start, via a joint proposal by the Industry and Commerce Ministry and Finance Ministry. Following the decision, the products entering the country are registered by the Customs authorities.

However, some cosmetics which fall under the borderline product category are being regulated at present, leading to an NMRA circular being issued restricting promotion of glutathione, directly or indirectly, as a ‘skin-whitening agent’ in advertisements.

The amendments to the Act will also include revisions on penalties given against those who violate the regulations outlined, NMRA Chairman Prof Asita de Silva said.

Speaking at a press briefing held yesterday, Prof. de Silva said that the penalties given to repeat offenders of the regulations currently was not sufficient, and would be increased through the amendment set to be finalized in August.

“In my opinion, those punishments are not enough and we are looking at it in the amendments which are now with the Legal Draftsman,” he said.

Prof. de Silva also said a number of other changes are also expected to come through the amendment, to ensure that the legislation is practically implemented.

Following the introduction of the NMRA and the price controls that ensued, there have been major savings for both individual patients and the Government, Prof. de Silva noted.

However he also said that the market share of the majority of commonly used drugs, including those used to treat non-communicable diseases, has increased, which Prof. de Silva attributes to uninterrupted usage, owing to price reductions making the drug more affordable.

“Patients now buy the drug and use it as prescribed, those days if they took the drug once in two days, as they cannot afford to take it continuously, they are now taking it every day. The results of this we will see in a few years’ time,” he said.

In 2016, the NMRA took steps to slash prices of 48 drugs, which included 273 brands, in some cases by about 55%. Prices of another set of drugs were slashed last year. The NMRA only allowed price revisions to reflect the dollar rate fluctuations. Accordingly, the market share of the drugs grew from Rs. 6.24 billion to Rs. 6.3 billion. The annual estimated savings on out of pocket expenses from the 48 maximum sales price impacted products for in 2017 was over Rs. 3.5 billion, while in 2018 the number increased over Rs. 4.5 billion, Prof. de Silva said. Total savings on out of pocket expenses over two years was Rs. 9.28 billion.

Despite the controlled price, Prof. de Silva noted that there has been a growth in market share of most of the popular brands, contrary to many critics of MRP when it was first introduced.