One of the most important changes is the acknowledgement and permission for retaining electronic records across various manufacturing and quality control activities. Earlier there was no mention of electronic records and companies were required to maintain only registers and printed records.
Dr. Saurabh Arora
Recently the Central Drugs Standard Control Organisation (CDSCO) released the gazette notification for the Cosmetic Rules Amendment 2025. This is a progressive move from the government reflecting the rapid growth and vibrancy of India’s cosmetics and personal care industry. The amendment addresses several long-standing gaps while giving much-needed focus to quality, record keeping, exports and regulatory clarity.
One of the most important changes is the acknowledgement and permission for retaining electronic records across various manufacturing and quality control activities. Earlier there was no mention of electronic records and companies were required to maintain only registers and printed records. Now under multiple clauses electronic records are officially permitted. This modernisation reduces administrative burdens and aligns with digital documentation practices used globally.
A major boost for exports comes from the simplification of labelling requirements for products meant for international markets. The amendment now specifies that exporters only need to include the neutral code. Previously even for exports companies had to include details such as batch number and expiry date on labels regardless of whether these were required by the importing country. Now exporters can label products in accordance with the importing country’s regulations while ensuring the neutral code is present. This is a critical step for Indian manufacturers to remain competitive globally.
To further strengthen quality oversight the amendment has clearly notified the Central Drug Testing Laboratory (CDTL) as the central laboratory for cosmetics as well. Earlier there was ambiguity over which laboratory would serve as the referral lab for cosmetics. Now CDTL is explicitly assigned these responsibilities in addition to its role in drug testing. This clarity will help in establishing consistent quality standards and ensuring effective reference testing.
Another significant provision is the requirement for manufacturers to test every batch of raw materials they purchase as well as every batch of finished products they manufacture. This mandatory batch testing ensures consistent quality and safety for consumers.
Furthermore records of these tests must be maintained both in printed registers and as electronic records for three years or for six months after the product’s expiry date whichever is later. This provision reinforces accountability and ensures that quality data is available for reference in case of disputes or regulatory reviews.
In an important move towards regulatory enforcement the amendment introduces a provision allowing the licensing authority to suspend or cancel a license in case of rule violations after issuing a show cause notice. This was not part of the earlier framework. By including this clause the regulator demonstrates its commitment to quality and compliance while signalling that serious breaches will invite proportionate consequences.
In another industry-friendly reform the amendment removes the requirement for regrant or renewal of licenses. Instead licenses will now be perpetual subject to periodic inspection. This mirrors the approach already implemented in the pharmaceutical industry where perpetual licenses have reduced administrative delays and allowed regulatory efforts to focus on inspection and compliance monitoring.
The amendment also addresses a long-standing ambiguity regarding expiry dates and best before dates. It now defines expiry as the last date of the specified month and best before as the first day of the specified month. This clarity will streamline labelling practices and prevent misinterpretation by both manufacturers and consumers.
Collectively these amendments reflect a strong push towards rationalisation and harmonisation with global standards. By easing export labelling requirements clarifying expiry definitions allowing electronic records and mandating quality testing the government is enabling Indian cosmetic manufacturers to operate more efficiently while meeting international expectations.
The Cosmetic Rules Amendment 2025 is not only a facilitator of industry growth but also a safeguard for consumer safety. The introduction of powers to suspend or cancel licenses reinforces the seriousness of regulatory oversight while mandatory batch testing and enhanced record keeping strengthen the foundation of quality assurance.
By formally recognising electronic records the rules acknowledge the operational realities of modern manufacturing. By aligning export labelling requirements with international norms they provide a competitive edge to Indian exporters. And by notifying CDTL as the reference lab for cosmetics they ensure a clear and consistent authority for quality verification.
The Cosmetics Rules Amendment 2025 is a well-balanced reform that addresses operational flexibility strengthens regulatory clarity and enhances quality control. For an industry that is proliferating with a large number of manufacturers and brands such measures are essential to maintain global competitiveness and safeguard public health.
It is a step forward in promoting the industry’s growth while ensuring that the products reaching consumers meet the highest safety and quality standards. By streamlining processes supporting exports and aligning with international best practices the amendment reinforces India’s position as a key player in the global cosmetics and personal care sector.
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