Karnataka Indian Medicine Manufacturers' Association (KIMMA) has questioned the appointment of the drug licensing authority Dr K M Nanjappa who also is the deputy director (Pharmacy), government Central Pharmacy. The Association has stated that his appointment is in contravention with provisions of the Drug and Cosmetic (D&C) Rules 1945.

Dr Nanjappa was appointed as Drug Licensing Authority for issue of licenses to ISM Drugs in Karnataka vide Government order aakuka: 503:PIM: 2005(1) dated 19-10-2006.

The order stated that in exercise of powers conferred on the State Government under Rule 162 A of the Drugs and Cosmetics Rule 1945, the Government appointed Dr Nanjappa as licensing Authority.

According to JSD Pani, secretary, KIMMA Rule 162 A did not empower the State Government to appoint a Licensing Authority but only prescribed the qualification and experience of the Licensing Authority for ISM Drugs.

The rule 162 A (inserted vide GSR No 76(E) dated 3-2-2003 w.e.f 3-2-2003) states that the basic qualification for State Licensing Authority for licensing of Ayurveda, Siddha and Unani drugs according to schedule II of GCIM Act 1970 is B Pharm ( Ayurveda) of a recognized University. The candidate should have a minimum of five years experience in the Ayurveda / Siddha/ Unani drug manufacturing or testing of Ayurvedic, Siddha and Unani drugs or enforcement of provisions of Chapter IV A of the D&C Act 1940 and rules made there under Or teaching /research on clinical practice of Ayurveda/ Siddha/Unani System.

"This being the situation the Government needs to change the order quoting the proper rules under which the Government is empowered to appoint the Licensing Authority, pointed out Pani.

The position of a Drug Licensing Authority is not a full time responsibility. According to the D&C Act, an officer of a particular designation is notified as a Licensing Authority and any person in that designation could perform the duties of the Licensing Authority.

Referring to the notification dated July 7, 1975 notifying the Director ISM and H as the Licensing Authority, KIMMA secretary said that the Government has notified not a designated Officer but a person by name as licensing authority. Now the Government needs to change the Notification notifying an Officer designate as a Licensing Authority.

Dr Nanjappa by virtue of his designation and responsibility, is the deputy director, Government Central Pharmacy which is an Ayurveda and Unani Drugs manufacturer under the D&C Act 1940 and has a valid Drug License under the Act.(Mfg Lic No AUS -3/73 dated 12-3-1973). Under the circumstances a licensee cannot be a licensing authority under the same legislation. Such an Officer holding the position of a Licensing Authority is bad in law, said Pani.

Government should immediately relieve Dr Nanjappa from his responsibility of heading the Government Central Pharmacy and give him a different responsibility and issue notification stating that designated Officer as Licensing authority in order to meet the requirements of the D&C Act so that notifying the Licensing Authority will be according to the D&C Act and Rules and Dr K.M Nanjappa also could continue to be the Licensing Authority.

KIMMA would also place the issue before the Principal secretary, Health and Family Welfare through a revised petition, informed Pani.