New e-platform to help India weed out substandard drugs
Unlike the US and Europe, India does not currently have a tracking system for the drug supply chain.
The country's drug regulator on Friday sought public comments on a proposal to start an electronic platform for tracking the supply chain to weed out substandard drugs, monitor adverse reactions and curb overuse of antibiotics.
Unlike the US and Europe, India does not currently have a tracking system in place for these purposes.
"The objective of such regulation would be to ensure availability of right drugs that meet the standards of quality to every person, in need of medicines, curbing antimicrobial resistance (AMR) and also regulating supply of medicines through online/internet to persons or other entities in outside India,” Central Drugs Standard Control Organization (CDSCO) said in its notification.
More than 10 percent of drugs in the government supply chain were found to be Not of Standard Quality (NSQ), according to the largest-ever survey by the Ministry of Health and Family Welfare, while the estimated percentage of NSQ drugs from samples taken from retail outlets across the country stood at 3 percent.
The regulator's notification said the electronic platform would be developed and maintained by an autonomous body under health ministry. The ministry will provide the initial grant and personnel while related expenses will be met by the Consolidated Fund of India for two years.
The e-platform will subsequently generate its own revenues through a small transaction fee, registration and renewal fee from pharmacies, e-pharmacies, wholesale, retail and manufacturing channels.
Below are some important proposals made by the drug regulator:
-All manufacturers will be required to register themselves with the said portal and enter data relating to sale of drugs on the said e-platform to different distributors (stockists/wholesalers) with batch number, quantity supplied and expiry date of the batch.
- All distributors will, also be required to register themselves on the said portal and enter details of stocks received and supplied by them to further distributors or retailers. The data can be entered both through online and by using mobile phones.
-The pharmacies located in rural and other remote areas can upload the data either through mobile phones or through internet at least once every fortnight.
- No retailer/chemist/e-pharmacist outlet shall be permitted to sell any medicine or drug unless such pharmacy is registered on the e-portal. The retailers will be required to enter all details of the medicines received, sold, returned to the manufacturer or disposed of in any other manner.
-No sale by e-pharmacy shall be permitted to be carried out by any person or entity unless, it has a licensed brick and mortar facility in each of the Licencing Authority’s jurisdiction.
-No sale of drugs shall be permitted by any entity beyond the area for which a licence has been granted.
-Medicines other than drugs included in Schedule H, H1 and X will be dispensed to any person only against prescription of a registered medical practitioner. However, in case of a few identified medicines, any other person specifically authorised (such as ASHA) to distribute a particular class of medicines may do so.
-The details of medicines dispensed will be entered in the e-platform and bills will be generated through the system. Such details will include prescribing doctor’s registration number (MCI or State Medical Council or the Dental Council of India) or other authorised person’s identity number, the name and registration number of the dispensing chemist and the quantity supplied, etc.
-The details of patient authorised person, etc. shall be kept confidential and shall not be disclosed to anyone other than the Central and State Drug Regulators or other officers authorised by the Central or State Governments. The details could, after removing the confidential information, be also made available to the Pharmacovigilance Programme of India (PvPI).
-At the backend, a system of audit by regulators for ensuring compliance with the Drugs and Cosmetics Act, 1940 and Rules thereunder will be developed. The audit will be facilitated through offsite analysis.
-The information collected may also be used by the Ministry of Health and Family Welfare, Government of India for such purposes as considered necessary in public interest.
-No export of anti-bacterial or any habit forming drug shall be permitted against internet orders.
-Any person or entity proposing to export other medicines/drugs on the basis of internet orders shall be required to be registered with the CDSCO and details of such registration will need to be mentioned in the invoice when exporting such medicines/drugs.- The revenue model could comprise a small transaction fee of not more than 1 percent of the total cost of medicines subject to a ceiling of Rs 200 per prescription, to be paid online by pharmacies/e-pharmacies/ wholesale/retail distributions, a small registration fee and renewal fee as may be determined by the government from time to time shall also be payable by manufacturers, pharmacies, hospitals and clinical establishments.