The small scale pharma industries in the country have sought prime minister's intervention to withdraw the DCGI's 'illegal directive' dated 15.1.2013 in which the DCGI has refrained state licensing authorities (SLAs) from granting permission for SLA-approved FDCs unless they have been approved by his office and displayed on website. Companies have also been asked to submit fee and data of all such existing drugs to DCGI for approval under Rule 122 of Drugs Act 1940 no matter for how long they were being manufactured.

Terming the DCGI's act an attempt to illegally over reach the Drugs Act 1940 and assume powers on entire range of medicines right from Independence till July 2002 - a period when he was not the designated authority as per Drugs Act, the SME Pharma Industries Confederation (SPIC) in a letter to Prime Minister Dr Manmohan Singh demanded to withdraw the 'illegal DCGI directive' in national interest.

Rule 122-E of Drugs Act which empowers DCGI to approve drugs before marketing in the country, based on which the directive dated 15.1.2013 has been issued, was first inserted by an amendment to Drug Act and Rules in 1988. Sub Clause (a) clearly indicates that drugs which are marketed in the country shall not require any prior approval by Central Licensing Authority (CLA) under Rule 21 of Drugs Act. Explanation given under this Rule specifies that all vaccines shall be New Drugs unless certified otherwise by CLA under Rule 21 of the said Rules, the SPIC letter said.

Subsequently on 17.8.1999, definition of the New Drug in Rule 122 was amended, which was implemented in July 2002, wherein following was inserted in Sub Clause (a) of said rule: “the drug to be marketed in India shall be recognised as effective and safe by Licensing Authority mentioned under Rule 21 for the purpose of Claims”.

Since Licensing Authority (LA) under Rule 21 was the SLA and not the DCGI and also because the qualifications of CLA and SLAs were same in Drugs Act, it is evident that permissions were legitimately granted by SLAs prior to 2002 for marketing of drugs with safety and efficacy of proposed claims. Hence many drugs were not included in the Approved List of DCGI in the period 1988 to July 2002, SPIC secretary general Jagdeep Singh argued in the letter.

FDCs like Glycodin, Vitazyme, Digene, pH-4 etc. have been used by us for four to five decades. Technically, they have successfully completed clinical trials phase III. If adverse reactions were reported then there was a provision to ban them under Section 26 long back. Long historical standing in the market is an acknowledged ground for safety and efficacy. That suddenly their safety and efficacy is being questioned by bringing them under the category of NEW Drugs only shows ulterior motives, the SPIC letter said.

Around 10 per cent directives of DCGI have withstood judicial scrutiny in the past because they are motivated and against the spirit of legislation. The present directive is in total violation of Drugs Act and has been issued with the sole purpose of handing over the FDCs market to MNCs/ Large industry on a platter because they have the resources to obtain DCGI approval.