केन्द्रीय सचू ना आयोग Central Information Commission बाबा गगं नाथ मागग, मनु नरका

Baba Gangnath Marg, Munirka नई दिल्ली, New Delhi – 110067 नितीय अपील संख्या / Second Appeal No. CIC/MH&FW/A/2023/645507 Shri Nagella Raveendra Babu … अपीलकताग/Appellant VERSUS/बनाम PIO, Ministry of Health & Family Welfare, …प्रनतवािीगण /Respondent Central Drugs Standard Control Organisation Date of Hearing : 27.01.2025 Date of Decision : 27.01.2025 Chief Information Commissioner : Shri Heeralal Samariya Relevant facts emerging from appeal:

RTI application filed on : 06.07.2023 PIO replied on : 04.08.2023 First Appeal filed on : 25.08.2023 First Appellate Order on : 18.09.2023 2ndAppeal/complaint received on : 21.09.2023 Information sought and background of the case:

The Appellant filed an RTI application dated 06.07.2023 seeking the following information:-

“What are the measures taken to control spurious drugs manufacturing, selling and distribution in India. With the advances in technology, medicines are being sold online. What are the means by which citizens can compliant about spurious drugs to authority. Is there any online complaint mechanism exists in the country? If online complaint mechanism exists, what measures have been taken to create awareness to the citizens. What is the turn around timeline for the complaint address mechanism. If online complaint mechanism does not exists, who is responsible for establishing this system. Please provide details/escalate this to the concerned department. Does Indiamart (https://www.indiamart.com/) authorized to sell medicines in India? Through this online route people are being cheated with spurious drugs.”

reproduced verbatim The CPIO vide letter dated 04.08.2023 replied as under:-

“Reply License for manufacture, sale and distribution in the country is regulated by the State Licensing Authorities appointed by the respective State Government are empowered to take action in case of any violation comes under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder. Further, CDSCO and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:

1. On 17-11-2022, the Drugs Rules, 1945 were amended vide G.5.R. 823(E) which has come into force on 1^st of August, 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule HZ, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication. The stored data shall include the following particulars, namely: (i) unique product identification code, (ii) proper and generic name of the drug, (i) brand name, (iv) name and address of the manufacturer, (v) batch number, (vi) date of manufacturing. (vii) date of expiry, and (viii)

Manufacturing licence number.

2. On 18.01.2022, the Drugs Rules, 1945 were amended vide G.5.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the minimum particulars including Unique product identification code, Batch No, MFG date, Exp. Date etc.

3. The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 το provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.

4. States/UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal

5. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been significantly increased in last 10 years.

6. To ensure e