68 Cases Of Unapproved FDCs Licensed By SLAs Reported During 2017-21

New Delhi : A total of 68 cases in which the Fixed Dose Combinations (FDCs) considered as new drugs unapproved by the Central Drugs Standard Control Organisation (CDSCO) getting licensed by State Licensing Authorities (SLAs) were reported during the period 2017 to 2021 till date, according to the Department of Pharmaceuticals (DoP). The highest number of such cases reported during this period was from Uttarakhand, followed by Maharashtra, Himachal Pradesh and Sikkim.

In 2017, 21 such cases were reported. Though the number of cases has come down to eight in 2018, it again went up to 17 in 2019 and 14 in 2020. During the year 2021, till date, eight such cases have been reported with the Central drug authority so far.

Of the total 68 cases during the period, 16 were from the State of Uttarakhand, 11 from Maharashtra, nine each from Himachal Pradesh and Sikkim, three from Uttar Pradesh, Gujarat, Karnataka, Puducherry and Daman & Diu, two each from Telangana and Tamil Nadu and one each from West Bengal, Jammu, Bihar and Assam, according to the data released by the Ministry of Chemicals and Fertilisers.

The Ministry, under which DoP operates, has said that in all such cases, the office of Drug Controller General of India (DCGI) took up the matter with respective SLAs and written to them for taking necessary action against such FDCs as per Drugs and Cosmetics Act, 1940 and Rules made there under.

“Further, the State Drugs Controllers have also been instructed from time to time in the Drug Consultative Committee meetings to ensure that new drugs and FDC are not permitted without approval from the office of DCGI,” said Minister for Chemicals and Fertilisers Dr Mansukh Mandaviya in reply to Unstarred Question Number 1042 in the Lok Sabha.

Responding to a question raised by Member of Parliament Dr Ram Shankar Katheria, the minister said that under the Drugs & Cosmetics Act, 1940 and Rules thereunder, permission is required for manufacture of any new drug from CDSCO before obtaining manufacturing license for the new drug from the concerned SLA.

Earlier, the government noticed some case of grant of manufacturing license of new drugs including FDCs by some of the SLAs without due approval of the DCGI came to the notice of the Government and apart from issuing repeated statutory directions under Section 33P of the Act, to the State Governments in this regard, the Central Government constituted an expert committee under the Chairmanship of Prof. C K Kokate to examine the safety and efficacy of such FDCs.

Based on the recommendations of the Prof. C K Kokate Expert Committee, the Central Government prohibited 344 FDCs, and this notification was quashed by the High Court of Delhi in 2016 following several petitions. The Government of India challenged this order before the Supreme Court through a Special Leave Petition (SLP). Further, 20 cases against five FDCs prohibited in June, 2017, were also transferred to the Supreme Court from various High Courts. The Supreme Court, in its order on December 15, 2017, directed that an analysis be made in greater depth and these cases of (344+5) FDCs should go to the Drugs Technical Advisory Board (DTAB) or a Sub-Committee formed by the DTAB for having a re look into these cases. The DTAB constituted a sub-committee, which submitted a report.

Following these recommendations of DTAB, the Central Government through a notification on September 7, 2018 prohibited 328 FDCs for manufacture, sale or distribution as there was no therapeutic justification for these FDCs and they could involve risk to human beings. The government also restricted six FDCs with certain conditions. However, various firms and stakeholders have filed writ petitions in various High Courts across the country including the Supreme Court against these notifications.

Further, the Central Government in line with the recommendations of DTAB, on January 11, 2019, prohibited 80 FDCs for manufacture, sale or distribution as there was no therapeutic justification for these FDCs and they could involve risk to human beings. These 80 FDCs were part of the list of 294 FDCs identified in the year 2007, which were earlier subjudice in the High Court of Madras, said the Minister.

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