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Health Ministry amends D&C Rules to permit sale of homeopathy drugs in general chemist outlets

Nandita Vijay, Bengaluru
Friday, December 1, 2017, 08:00 Hrs  [IST]

The Union government has issued a notification mandating a slew of norms to strengthen the homeopathy system of medicine.  These include the need for a competent licensing authority to deal with homeopathic medicines and be qualified with a degree in this medical speciality. Homeo drugs can be sold at general pharmacies under separate license and to be stored separately from allopathic drugs.

The revision is listed in the Drugs and Cosmetics 11th Amendment, 2017 and is published in the latest Gazette No. 918.

If the candidate issuing licenses  is not qualified in homeopathy, a pharmacy degree from a recognised university is acceptable. Alternatively the candidate could be a  bachelor’s degree holder  but should have a one-year experience in  dispensing homeopathy  medicines at a clinic of  registered homeopathy practitioner and have a license as per Form 20C or Form 20D, as per the regulation.

Another option  given by the Ministry of health and family welfare is that the candidate could also be a diploma holder in homeopathic pharmacy or a diploma in homeopathy medicine and surgery.

Under Rule 67G of clause (2) calls for supervision of a person having a qualification referred to in sub-rule 1of rule 67F. It also includes manufacturer’s sealed packing except for dispensing medicines in globules, water or milk and sugar or as per prescription of homeopathy medical practitioner.

In Rule 85E, after sub-rule will be substituted as (2A) on certificate of good manufacturing practices. Here manufacturers need to comply with the certificate of good manufacturing practices as specified in Schedule M –I.

In Schedule K for the serial number 31 and the entries relating to the exemptions provisions of chapter IV of the Act and rules, now calls for sale license in Form 20C where the conditions are that the  medicines should be sold in the original sealed small quantity packs of the licensed manufacturers. The medicines need to be stocked and sold by retail dealers of the medicines under Rule 61. These medicines will need to be purchased from a manufacturer or a dealer. Purchase and sale records of medicines will need to be maintained by the dealer for a minimum period of three years.

Further the new notification calls for deletion of words. These include under Schedule M-I in paragraph 1 relating to General requirements in sub-paragraph 1.1 where  the words ‘or outside’ will be omitted. In paragraph 2, relating to plant and equipment, in sub paragraph 2.1, for the word ‘origins’ will be replaced with ‘types’. In paragraph 3 related to Requirements of equipment and facilities, will now mandate use of stainless steel of grade not below 304 and the area allocation will now be not less than 55 square metres.

Commenting on the amendments Nishant Jain, CEO, B Jain Pharmaceuticals said that changes in Schedule K  is favorable for the growth and availability of the homeopathic medicines.  It ensures that  homeopathic medicines are accessible at  allopathy chemists  without any extra license, which was earlier restricted to be sold from specific homeopathic pharmacies.

Another aspect is the Certificate of Good Manufacturing where companies are at  ease with annual renewal of the license which will help to keep things more under control and check, he added.

 

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