India
ASOP Global has launched a local chapter in India to educate and protect Indian consumers from illegal online sale of medicines. The ASOP Global India Chapter will promote public health and educate and protect patients in India from unsafe medicines sold via the internet and made available outside of the legitimate supply chain.
The mission of the India Chapter is to engage with the government, patient and consumer organizations, industry associations and other stakeholders to increase public awareness and to address the threat from sale of illegal, unsafe, spurious, substandard and falsified medicines from online pharmacies in India and globally.
The ASOP Global India Chapter will be led by Bejon Kumar Misra, Founder of Patient Safety and Access Initiative of India Foundation and advisor to the ASOP Global India Chapter.
Buying Medicines Online in India
The Internet is the biggest unregulated market in the world. The World Health Organization (WHO) suggests that over 50% of medicines purchased on the internet from sites that conceal their address may be substandard or falsified. Many consumers are unaware that a large number of online pharmacies are not regulated and that there is a very high chance that medicines purchased online are falsified/substandard.
The Government of India will soon complete and release new legislation and regulations covering the registration and sale of prescription drugs by on-line and off-line pharmacies. The ASOP Global India Chapter is working closely with Ministry of Health & Family Welfare, Government of India and Central Drugs Standard Control Organization (CDSCO) concerning this new legislation and will offer technical assistance in building awareness and national best practices on the various provisions of the existing laws to further strengthen the implementation of the new legislation and regulations.
During March 2018, ASOP Global organized a two-day international Forum in Delhi, India titled “Patient Safety and Access to Safe Online Pharmacies” with representatives from the Government of India, Indian Pharmacopeia Commission, International Alliance for Patients’ Organizations (IAPO), Partnership for Safe Medicines (PSM) India Initiative and USP. The details of the event are included on the following website: www.safemedicinesindia.in.
Government of India, Office of the Drug Controller General
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
Major functions of CDSCO are:
- Regulatory control over the imported drugs,
- Approval of new drugs and clinical trials,
- Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and
- Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarter.
Under the Drugs and Cosmetics Act, the regulation of manufacture, sale and distribution of drugs is primarily the responsibility of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials, establishing standards for Drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations and providing expert advice to establish uniformity in the enforcement of the Drugs and Cosmetics Act.
The Drug Controller General of India is responsible for approval of licenses of specified categories of drugs, such as blood and blood products, I. V. Fluids, Vaccines and Sera.
India State Regulation and Enforcement
Each Indian State has regulations for international drug sales from licensed pharmacies. As health-related activities are under a State government control, the central government only plays an advisory role towards effective implementation of all the existing laws like the Drugs and Cosmetics Act and others. The proposed new regulations and amendments to the existing law by the Government of India on drug sales will establish new requirements that each Indian State would need to consider and comply with including:
- Each pharmacy would need to be a licensed brick-and-mortar pharmacy; and
- The pharmacy would be required to display the license number, address, phone number and contact information.
Internet pharmacy businesses must comply with all federal and provincial practice laws and be available for on-site inspections by provincial colleges of pharmacy (boards) as part of an accredited pharmacy.
Report a Suspicious Website
If an Indian consumer thinks a website is selling medicines illegally or has any safety issues including adverse drug reactions, please call the following toll free helpline -1-800-11-4424 or contact at bejonmisra@safemedicinesindia.