LIST OF DATES AND SYNOPSIS

The petitioners have invented a Herbal medicine by name IMMUNO HERBAL SUNJEEVI "Balaji Amruta" for curing AIDS patients. The medicine was put to test for a committee of three Ayurvedic doctors and it was administered to AIDS patients who were in advanced condition. The patients who were in dying condition became symptoms free and however they remain HIV positive asymptomatic and leading normal lives. The petitioners as per guidelines of Andhra Pradesh Government applied for obtaining manufacturing licence for product and manufacturing of the said medicine as per the guidelines issued under 'Indian Medicines & Homeopathy Dept. Government of Andhra Pradesh vide Good Manufacturing Practices Guidelines Ayurvedic & Unani. The Second Respondent issued an application and adviced the petitioners to comply with all necessary conditions, accordingly Petitioners submitted Form-24-D and also submitted with 10 bottles of sample medicine.

The petitioners submit that second respondent is statutory regulating body under Rule 153 of Drugs and Cosmetics Rules, 1945 to grant manufacturing licence to the petitioners. Upon refusal of permission the petitioners filed Writ petition in Delhi High Court on 02.12.02 CW 7790/2002. The Hon'ble Delhi High Court on 12.12.2002 dismissed with a direction to approach R-3, i.e. Licensing authority as matter was pending. The petitioners submitted to Hon'ble High Court order with the licensing authority. The second respondent vide Letter No. 19059/DA/2002, dated 31.12.2002 returned the original Application along with its enclosures with an endorsement.

"AIDS is one of the listed diseases under the rule 106(1) under Schedule "J" of Drugs and Cosmetics rules 1945. The rule specifies that no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule "J".

Thus the petitioners challenged the above rule as unconstitutional as the rule taking away the very fundamental rights of both inventors of AIDS cure medicine and AIDS patients by not allowing them to consume the AIDS cure herbal medicine which is invented by the petitioners. Surprisingly the court below without considering the contention of petitioners, the advisory note second para of Commissioner letter took into cognizance and the same was not challenged by the petitioner. Whether the Commissioner is competent to advise and issuing of manufacturing licensing is purely regulated by Central Act Drug & Cosmetics Rules, 1945

The court below contended that ICMR, CCRA and Drug Control General have been constituted under various legislations. The above bodies are constituted by the first respondent and they are not statutory bodies. The second respondent is duty bound to refer the petitioner's medicine to first respondent and first respondent has to refer the petitioners medicine to above institutions. As per Article 12 First respondent and Second Respondents are State and both of them are statutory authority. The petitioners medicine is a life saving drug for AIDS patients who are dying within a short period. The petitioners constituted Ayurvedic doctors committee (Dr. Suryakumar & 3 others). This committee has treated 30 AIDS advanced stage patients. Who were treated by this herbal combination and the said 30 AIDS patients from dying stage recovered with full health, however they remain HIV Positive without any symptoms.

AIDS patients who are in advance full blown stage, there is no question of treatment by any doctors even under modern medicine. The petitioner's medicine will be much useful for AIDS patients and, petitioners were ready to constitute committee under this Hon'ble court and 30 AIDS advanced stage condition patients be given to petitioners under supervision of First respondent, and petitioners are ready to cure them. The petitioners challenge the Rule 106(1) r/w Schedule J of Drugs and Cosmetics Act, 1945 India is taking away the right of inventors for providing curable medicine and also it takes away the right to life guaranteed under Article 21 of Constitution of India, hence the rule with Schedule J are liable to be struck down as unconstitutional, hence the present Special Leave Petition.