Dr KK Aggarwal

In 2017, the US Food and Drug Administration (FDA) barred the use of 24 ingredients, including triclosan, in over-the-counter (OTC) antiseptic products such as hand washes and surgical hand scrubs. Though these products were an important component of infection control strategies in healthcare settings, there was fear that they may contribute to antimicrobial resistance if they were not manufactured or used appropriately.

FDA also deferred grant letters for six of the most commonly used antiseptic ingredients—alcohol (ethanol), isopropyl alcohol, povidone-iodine (betadine), benzalkonium chloride, benzethonium chloride, and chloroxylenol (Dettol). It has been deferred from the final rulemaking so as to establish that they are recognized as safe and effective. The final rule did not apply to consumer antiseptic washes or rubs, first aid antiseptics or antiseptics used in the food industry.

Of the 24 active ingredients that the FDA found non-GRASE, triclosan is the only one currently being used in any marketed healthcare antiseptic product. So most currently marketed healthcare antiseptics had no impact by this final rule. Of late in India, Colgate Palmolive removed triclosan from its toothpaste and HUL replaced it from its soap.

Now the Drug Controller General of India has formed an expert panel to determine whether OTC healthcare products such as Dettol (Chloroxylenol, terpineol and absolute alcohol) and Savlon (cetrimide and chlorhexidine), both popular first-aid products, should continue to enjoy exemptions under “antiseptics” and “disinfectants”. Currently, they are exempted under Schedule K of the Drugs and Cosmetic Rule. Another antiseptic, Povidone iodine (Betadine), does not come under this Schedule K.  Clause 12, Schedule K of the Drugs and Cosmetics Rules governs “substances intended to be used for destruction of vermin or insects, which cause disease in human beings or animals, viz insecticides and disinfectants”.

As per the provisions of Section 123 of the Drugs and Cosmetics Rules, drugs specified in Schedule K of the Drugs and Cosmetics Rules shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.

The clause 12 is subject to the condition that provision of condition (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945 are complied with by the person stocking or selling such substances.

The provisions of Rule 65(17) of the Drugs and Cosmetics Rules are as reproduced hereunder:

“No drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper: Provided that any such drugs in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks and all such drugs shall be kept in packages or cartons, the top of which shall display prominently, the words ―Not for sale.”

Currently as per the rules both Dettol and Savlon can be stocked, exhibited and sold without a licence. No prescription of the registered medical practitioner is required for purchasing these antiseptic medicines.

However, the matter has now been referred to a subcommittee for re-examination. The experts will hold debate on whether these products can be considered under the OTC category or no-prescription products and continue existing exemption from the sale licence.

The question now is should antiseptics be taken out of OTC list on the question of their possible role in antibiotic resistance.

India is facing an epidemic of antimicrobial resistance.  Antibiotic misuse is a major concern even though antibiotics are classified under schedule H or H1 of the Drugs and Cosmetics Rules.

Though, as per the provisions of Drugs and Cosmetics Act and Rules, the drugs mentioned in Schedule H or H1 can be bought or sold only with the prescription of the registered medical practitioner. However, in practice, most of them can be procured without prescription or prescribed by non MBBS non BDS doctors.

The pharmacies are also selling antibiotics mentioned in Scheduled drugs without even asking for the prescription of the registered medical practitioner.

Apart from the above, self-prescription of antibiotics, pharmacist prescribing antibiotics for minor complaints and prescribing topical antibiotics when topical antiseptics can work is routine in practice, though the same is against law and no action is being taken against the same.

On priority antibiotics needs to be regulated more stringently and all of them should be regulated under schedule H1 or schedule X of the Drugs and Cosmetics Rules.

It is true that there is a concern about misuse of antiseptics (Dettol and Savlon and not betadine) as they can cause resistance in their antibacterial, antiviral and antifungal actions.

No acquired bacterial resistance or cross-resistance has been reported for iodine. This lack of selection for resistance that limits the utility of conventional antibiotics and antivirals is attributed to the non-specific multiple modes of action of PVP-I.

On the other hand, bacterial resistance to chlorhexidine, has been documented. Genes conferring resistance to chlorhexidine and quaternary ammonium compounds have been identified in up to 42% of S. aureus isolates in Europe and Japan.  Cross-resistance between antiseptics has also been reported, but PVP-I has remained unaffected.

Studies have also documented cross-resistance between antiseptics and antibiotics. A potential risk of cross-resistance to the last-resort antibiotic colistin emerging in Klebsiella pneumoniae due to exposure to chlorhexidine has been reported in Antimicrobial Agents and Chemotherapy. PVP-I is a preferable alternative to antibiotics in the prophylaxis of wound infection.

But the priority in the country is on antibiotics. When choosing between two evils we need to choose a lesser evil. For example, under tobacco harm reduction strategy we should ban tobacco but as the same cannot or is not being done the policy should allow less harmful non-tobacco products as OTC.

Similarly, till antibiotics resistance problem is totally regulated and implemented it will not be right to shift antiseptics (Dettol and Savlon) which are first aid medicines to a non-prescription drug category. Also, all over the world the major problem is with triclosan and not other antiseptics.

Multiple products in India use triclosan and triclocarban, including some popular soaps and hand-washes. The DCGI should ban triclosan from all consumer products and work on antibiotics problem on priority and should not ban first aid medicines/ antiseptic.