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Ayush ministry to amend D&C Rules to add guidelines & standards for new dosage form of nasal spray
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Gireesh Babu, New Delhi
December 18 , 2023
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The Union Ministry of Ayush is framing guidelines under the Drugs and Cosmetics Rules, 1945 for issuance of license to the Ayurveda, Siddha, Unani and Homoeopathy drugs with the new dosage form of nasal spray in these systems, that are different from the traditional Nasya treatment.
A draft notification with proposed amendments to the Drugs and Cosmetics Rules has been released by the Ministry to set standards for the new dosage form nasal spray in these systems of medicines and the guidelines for the usage of the new devices, for regulatory purposes.
The draft notification has been prepared after consultation of Ayurveda, Siddha, Unani Drug Technical Advisory Board and the ministry has called for objections and suggestions from the stakeholders in 30 days from the date on which copies of the Official Gazette with the draft is published.
The notification suggests addition of a new sub-rule in the Rule 158B, which details the guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs, that for issue of license to drugs with nasal spray as dosage for in these systems of medicines, the Licensing Authorities shall follow the guidelines as per Schedule TB. Amendment shall also be made in the Schedule M-I to enforce the same for the homoeopathy medicine with nasal spray as dosage form, it said.
The Schedule TB is also a fresh addition suggested in the draft notification, which details the definition of a nasal spray, differentiating it with the traditional Nasya and putting guidelines for ingredient selection, excipient selection, and other specifications and parameters for the device and finished products, among others.
"A nasal spray is a liquid/powder formulation dispensed as a fine spray from a container/device into the nostril. In this combination of formulation and device, the end user sprays the nasal spray formulation into the nostril while breathing in through his/her nose. Nasal sprays are used to deliver medications locally in the nasal cavity," the new guideline defines.
Though the route of administration for Nasya and nasal spray is the same (nose), the main differentiating aspect between traditional Nasya and the new dosage form of Ayush nasal spray is that 'in the traditional method medicated juices/oils are administered through the nasal route without the support of any specialised instrument/ device. Whereas the nasal spray is administered by using a specific device', it said.
"The present definition or introduction of nasal spray shall not interfere with the existing nasal drops used in the form of oils or decoctions etc. The respective existing Nasya methods shall continue," it added.
The medication standards for those items remain to be the same as indicated in the Ayurvedic Pharmacopoeia of India (API), Part-II (example for Anutaila and Shadbindu Taila). The Standard Operating Procedures (SOPs) for the performance of Nasya shall also be the same as those developed by Central Council for Research in Ayurvedic Sciences (CCRAS) at National Institute for Panchakarma, Cherthurthy, Kerala.
Setting standards for the new dosage form “Nasal Spray” and the guidelines for the usage of the new device it said that the active ingredients should be selected as per the definition of the ASU Drugs in Section 3(h) under the Drugs and Cosmetics Act, 1940 and excipients should be selected as per the provisions and terms and conditions provided under Rule 169 of the Drugs and Cosmetics Rules, 1945 and its amendments. It also sets specifications for the device and the finished products.
The amendment also suggests that one-time studies preferably performed on three or more batches of the product should be submitted along with the license applied as part of product development, as mandatory.
Broadly safety and efficacy studies need to be conducted as per the guidelines provided in Rule 158(B) of the Drug and Cosmetics Rules, 1945 and Amendments as well as those provided in General Guidelines for Safety/ Toxicity Evaluation of Ayush formulations, CCRAS, Ministry of Ayush, Government of India.
As per the requirement, safety/toxicity of the intended therapeutic formulation in its final form must be justified through appropriate means as relevant, such as ingredient literature as per text, indication (e.g. textbook rationale), classical medicine or proprietary medicine, hydro-alcoholic extract or other, mucosal irritation test on experimental animals and/or clinical studies on safety, efficacy and tolerability as per Good Clinical Practice guidelines for clinical trials in Ayurveda, Siddha and Unani medicine (GCP-ASU), 2013 and ICMR - National Ethical Guidelines For Biomedical and Health Research involving Human Participants- 2017 and other guidelines as appropriate.
The guidelines elaborated the traditional concept of Nasya, stating that any medicine administered through the nose (Nasika) is considered Nasya (nasal administration) in Ayurveda. Usually, all the clinical conditions related to head and neck are treated by following Nasya as the main line of treatment. In conditions like Apasmara and Unamada, procedures like Pradhamana Nasya provide instant relief by reflex or systemic action.
There are several varieties like Snehana Nasya (medicated oil/ghee used as nasal drops), Shamana Nasya (fresh herbal juices/decoctions used for nasal administration), Avapeedana Nasya (fresh herbs squeezed and the juice used as nasal drops), Pradhama Nasya (powdered herbs forcedly sprayed into the nose) and Dhumana Nasya (medicated fumes inhaled).
The Nasya procedures like Snehana, Avapeedana Nasya etc. are used in the gravitational direction as the other methods like Dhumananasyaand Pradhamananasya are used against gravitational force.
In Siddha system, Nasiyam (nasal drops) and Nasika aparanam (Medicated snuff) are the types of external medication applied through nostrils. Nasiyam (nasal instillation) is a process of instillation of drugs in liquid form through the nostrils while Nasika aparanam (medicated snuff) is inhalation of medicated substances in powder form.
In the Unani system, various nasal dosage forms are used and most are nervine tonics and stimulants, especially helpful in neurological diseases. Dosage form of Nasal drop or fine powder used in the Unani system of Medicine comes under Drug & Cosmetic Act.
In Homeopathy system, administration of medicine through nasal route is mentioned under authoritative books of Homoeopathy medicines.
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