At a time the Drug Controller General of India (DCGI) is completing three years in service on deputation, his appointment is being challenged in the Madras High Court by a former regulatory officer of the Tamil Nadu Drugs Control Department.

The petitioner, T K Ramalingasamy, former joint director with TNDC, through his counsel submitted that while appointing Dr Surinder Singh as DCGI, the Government of India and the Union Public Service commission have not followed all the provisions of Drugs & Cosmetics Act and Rules. He prayed to the court to direct an inquiry into the selection process of the current holder of the highest statutory post of drug regulation and pleaded for framing of rules for the selection and appointment of candidates for the DCGI post.

According to Ramalingasamy, Dr Surinder Singh lacks expertise and experience in manufacturing or testing of drugs and enforcement of the Act for a minimum period of 5 years. These qualifications are mandatory under Rule 49 A of drugs and cosmetics in addition to the educational qualifications. Since DCGI is both Licensing as well as Controlling authority under the Act and the Rules, experience in pharmaceutical side forms part of ‘high standard of qualification’ as prescribed by the D&C Act and Rules for the selection purpose of the DCGI, he said in his affidavit.

The petitioner’s contention is that only an officer of the central or state drug regulatory department through his experience and expertise can carry out the functions of the supreme regulator for the sake of the national pharmaceutical market. The statutory functions of DCGI include laying down standards of drugs, cosmetics, diagnostics and devices. Lay down regulatory measures, amendments to Acts & Rules, regulate market authorization of new drugs and clinical researches in the country, approve licenses to manufacture certain categories of drugs, regulate the standard of drugs etc. An officer like Surinder Singh is not fit to carry out all these duties as he is a non-pharmacy graduate officer, Ramalingasamy said.

It is submitted that the authorities have not cared to verify the qualifications of persons holding responsible posts and working in related departments while selecting a candidate as the head of the drugs and cosmetics industry. In addition to the 5 candidates short listed for interview, out of the total 26 applicants, there were other 6 candidates who were more qualified and suited for the post than the shortlisted persons. But they were not even called for the interview, says the affidavit.

The petitioner said Dr Surinder Singh was made “In-charge DCGI” from 01-02-2008 to 09-08-2008 and on 10-08-2010 he was appointed as the regular DCGI on deputation basis. Even before the interview for the deputation post was held, he could assume charge as in-charge Director General which helped him to wield considerable influence and a say in the selection processes.

The affidavit says that after assuming charge as DCGI, Dr Surinder Sing has done so many alarming actions like issuance of circular to all the state Drug Control Officers that the COPP would be issued through his offices in future, permission to manufacture the emergency contraceptive pill marketed in the name I Pill etc.

It was evident from observation that the DCGI is indifferent in so many matters for which the petitioner submitted examples. The lack of proper supervision through state authorities for the HPV vaccination drive in Andhra Pradesh that created many a tumult in the pharmaceutical industry and headache for the state health department. The office of the DCGI is also not regular in calling Drugs Consultative Committee, which is constituted by the central government.

 It is further submitted that DCGI has not undertaken inspections on foreign manufacturers which led to the inflow of Chinese drug materials into Indian market. Though the Act prescribes that DCGI should hold meeting and coordination with state licensing authorities, Dr Surinder Singh has stopped this system which caused many problems in several states.