Rule 106 was incorporated in ‘The Drugs and Cosmetics Rules 1945, and the same rule was incorporated by Schedule J substituted by GSR21(E) dated 11.01.1996 (w.e.f. 11.01.1996). The true copy of Rule 106 along with Schedule J dated 22.06.1954 is annexed as Annexure P-1 Colly.

The petitioners collectively submitted an application on Form 24D as per Rule 153 of Drugs and Cosmetics Rules 1945 with second respondent for grant of licence Ayurvedic Drugwith 30 clinical reports and 10 samples of drug. A copy of coering letter along with Form 24-D dated 16.09.2002 as annexed herewith as Annexured P-3 Colly.

The Petitioners Full Time Technical Supervisor Dr. K. Surya Kumar M.D.(Ayu) submitted a letter to Union Minister for Health & Family Welfare at Nirman Bhavan and expressed his opinion of efficaoucy of medicine. A copy of letter dated 15.10.2002 is herewith annexed as Annexure P-4.

Petitioners filed Write Petition in Delhi High Court challenging inaction of licensing authority

Hon’ble High Court dismissed Writ Petition CW No.7790/2002 with a direction to licensing authority to pass appriate orders. A copy of order CW No.7790/2002 dated 12.12.2002 is annexed herewith as Annexure P-5.

In pursuant to court direction Respondent No.2 returned application based on Rule 106(1) r/w Schedule J of Drugs and Cosmetics Rules 1945. A copy of letter No.19059/DA/2002, dated 31.12.2002 is annexed herewith as Annexure P-6.

The petitioners filed a Civil Writ Petition CWP No.434 of 2003 challenging Rule 106(1) r/w Scheduled of Drugs and Cosmetics Rules 1945 as unconstitutional and Ultravires. A copy of Writ petition dated 07.01.2003 is annexed herewith as Annexure P-7.

The Hon’ble Delhi High Court without examining the plea of petitioners without giving reasonable opportunity to Respondents and merely based on Licensing Authority formal advice dismissed the Writ Petition.