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Scrap e-portal, e-pharmacy provisions in draft Drugs Sale & Distribution Rules, 2017: IPA

Laxmi Yadav, Mumbai
Monday, November 27, 2017, 08:00 Hrs  [IST]

The Indian Pharmaceutical Association (IPA) has urged Union health ministry to scrap provisions pertaining to the regulation of sale of drugs through e-portal and implementation online pharmacy proposed in the draft Drugs (Sale and Distribution) Rules, 2017.

Kaushik Desai, general secretary, IPA in a letter to under secretary (Drugs), ministry of health and family welfare on November 22, 2017 has stated that the country's poor IT infrastructure is a major roadblock to the implementation of e-portal. Even cities have poor internet connectivity. Considering this, it will be difficult for most of the chemists to upload the details of the sale on the e-portal. We often come across GST and other electronic portals crashing because of overload.

Draft Drugs (Sale and Distribution) Rules, 2017 proposed to set up an e-portal wherein all manufacturers, stockists and retailers are required to register themselves and enter data relating to sale of drugs with batch number, quantity and expiry date through both online and by using mobile phones.

Desai said that regulation of sale of all the drugs through e-portal is impractical. This can be initially tried for drugs under NDPS. Then subsequently psychotropic drugs/substances.

IPA opposing the operation of e-pharmacy stated that the country is not yet ready for it. “We request the regulatory authorities to first ensure that existing drug laws are implemented in the existing brick and mortar pharmacies and then we can think of e-pharmacies. Online pharmacies are openly operating currently in spite of them being illegal. The drug regulatory authorities should first stop the sales/operations of these illegal e-pharmacies,” said IPA general secretary.

The pharmacists' body has suggested certain changes in the draft which is set to replace provisions related to sale of drugs in Drugs and Cosmetics Rules. It said the word 'electronic prescription' mentioned in 3 (I) rule of the draft should be deleted. The rule shall incorporate typed/computer printed prescription but duly signed by the registered medical practitioner. There shall be a separate schedule in the rule dealing with typed or computer printed prescriptions for drugs listed in the Sixth Schedule and for drugs licensed under the NDPS Act which is currently not applicable.

The rules talk about e-prescription but definition of e- prescription is not there. A hard copy prescription obtained by a patient and scanned and sent to a pharmacy is not legal/valid, not permitted, it says.

The rules need to be more clear on prescriptions written by AYUSH practitioners. There is no mention of cutting of a strip, good pharmacy practice (GPP) in the rules. GPP is defined as "the practice of pharmacy that responds to the needs of the people who use the pharmacists' services to provide optimal, evidence-based care. To support this practice it is essential that there be an established national framework of quality standards and guidelines.”

The rules do not have provision for separate forms for retail, wholesale, hospital pharmacy. The application forms for retail, wholesale and hospital pharmacy should be separate and specific, bearing separate form number. Eg. RSl (for retail) HSl (for hospital) WSl (for wholesale), said IPA.

It termed clause, which does away with requirement of registered pharmacist for the sale of over the counter drugs specified in third schedule, dangerous and appealed to the ministry to delete it. OTC medicines can be sold only through a pharmacy, where a pharmacist is present. India is not ready for a situation yet where OTC medicines can be sold in general stores, etc because medicine literacy is not yet developed in majority of the population. There is absolutely none or negligible information about responsible use of the medicine on the medicine package (unlike other developed countries, where detail information about safe use of OTC medicines is available), added Desai.

Besides this, storage conditions and other operational details for vehicle used by retailers, wholesalers to distribute drugs should be mentioned properly in the rules, it suggested.

 

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