What is BIHRT? Is it legal to compound and manufacture BIHRT in India

What is BIHRT?

Bioidentical Hormone Replacement Therapy. BIHRT is the use of supplemental doses of hormones that have a chemical structure identical to the hormones that the human body naturally produces.

Query:

I have a query regarding the regulatory requirements of compounding pharmacies in India.
Do Bioidentical hormones come under the category of Ayurvedic medicines. Is it legal to compound and manufacture BIHRT in India as many wellness clinics are doing it already.
I would be obliged if you could help me with this query.

Response:
Bioidentical Hormones are Chemical Compounds that are similar to Body natural hormone. These are manufactured synthetically and FDA do not approve the word BIHRT. These are not Bio identical to hormones but totally synthetic and chemically prepared and come under Pharmaceutical Hormonal section and requires same criteria for selling, prescribing and manufacturing as of other natural and synthetic Hormones. They are manufactured under strict manufacturing regulations.

If Wellness clinics are doing it. They shall be performing it under registered Dermatologists prescription and under guidance of registered pharmacist only. Proper licensing and approval is required from Drug Control Department. For compounding of any pharmaceutical product at pharmacy require prior approval from Drug Department.

Most probably chances are wellness clinics are using packed or finished good preparations of these hormones manufactured by pharmaceutical manufacturing companies under proper licensing and approval. Compounding possibilities at own pharmacies are very less in their pharmacies. In India, number of compounding Pharmacies are very less at present. Most of pharmacies only dispense medicines, not involve in compounding.

If you want to establish a compounding pharmacy then you will require a pharmacist. Compounding of any pharmaceutical preparation is underdone only against prescription of medical practitioners specified the reason of compounding i.e. unavailability of particular drug or shortage in market or commercial available drugs are not suitable with patients requirements. If similar product is available in market then compounding of that product can’t be done. Along with pharmacist, A area of ten square meter with additional space of six square meter for compounding of medicines per pharmacist and for addition pharmacists, two square meter per each pharmacist is required. And you have to apply for pharmacy license specifying compounding of drugs.

As per our knowledge, compounding of medicines are restricted to solid or liquid dosage form that don’t required any special environmental or temperature conditions i.e. sterile or low temperature storage etc. Hormones are sensitive preparations and could be spoiled at some temperature variation. Hence compounding of BIHRT is not legal in India. Only licensed manufacturer can manufacture it. But you can confirm it from Drug authorities while you will apply for compounding pharmacy license.

Hope Above information is helpful to you…

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