1. Heard Mr.G.Masilamani, learned Senior Counsel appearing for Mr.C.Mohan, learned counsel for the petitioner and Mr.S.Haja Mohideen Gisthi, learned Senior Central Government Standing Counsel appearing for the respondents.

2. Challenging the Notification dated 10.02.2011 issued by the 1st respondent in GSR No.82 (E) published in Gazette of India Extraordinary Part--II Section 3-sub-section (i), seeking to quash the same in so far as it relates to Item No.3 viz., Phenylpropanolamine with a direction to the respondents to review the prohibition after giving an opportunity to him, the petitioner has come up with the present writ petition.

3. Facts, in a nutshell run thus :

3(i). Chemical, Industrial & Pharmaceutical Laboratories of India, popularly known as CIPLA, the petitioner herein, was formed in the year 1935. It is among the largest pharmaceutical Companies in India with a gross annual turnover of more than Rs.5,000 crores per annum. In the year 1952, a research division was set up by the petitioner with the view to attain self-sufficiency in technological development and since then, the petitioner has been progressing steadily in pharmaceutical, medicinal and drug development fields. At present, the petitioner has 31 world-class manufacturing facilities spread across the country with dedicated plants for oncology products, hormones, inhalers, carbapenems and cephlosporins among others. The various manufacturing facilities of the petitioner have been approved by several regulatory authorities, (both national and international) including :

(i) Food and Drug Administration (FDA), USA;

(ii) Medicines and Healthcare Products Regulatory Agency(MHRA), UK;

(iii) Therapeutic Goods Administration (TGA), Australia;

(iv) Medicines Control Council (MCC), South Africa;

(v) National Institute of Pharmacy (NIP), Hungary;

(vi) Pharmaceutical Inspection Convention (PIC),Germany;

(vii) World Health Organisation (WHO);

(viii) Department of Health, Canada;

(ix) State Institute for the Control of Drugs, Solvak Republic and

(x) ANVISA, Brazil.

3(ii). According to the petitioner, their Active Pharmaceutical Ingredients (API) manufacturing plants are amongst the most sophisticated plants in the world, capable of complex multi-storage synthesis producing over 120 API's from high potency actives in grams to those made in several tonnes. The petitioner produces one of the widest range of products and dosage forms in the world today including metered-dose inhalers, pre-filled syringes, trans-dermal spray patches, lyophilized injections, nasal sprays, medical devices and thermolabile foams. The petitioner was the first company in the world to offer the Triple drug AIDS cocktail for less than $1 a day to patients in several countries. In fact, one out of every three patients in Africa suffering from HIV AIDS, who are under treatment, are using the drugs/medicines manufactured by the petitioner.

3(iii). The petitioner would submit that Phenylpropanolamine (for short 'PPA') is a synthetic sympathomimetic amine, which is commonly used in cough and cold preparations and is also used as a nasal decongestant and respirator. The petitioner has been selling products with PPA for the last 20 years and the products containing PPA have been duly approved by the relevant authorities under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the 'Act') without any objection or complaint of after/side adverse effects. PPA is openly sold in USA, UK, Japan and in neighbouring Asian countries and the ban on the sales of products containing PPA with immediate effect is completely illegal, unlawful and contrary to law. The proposal for the ban of the said drug ought not to have been kept as closely guarded secret, but it should have been transparent and all the stake-holders ought to have been consulted and considered, as the drug is openly available in most countries of the world on prescription or over the counter. It is noteworthy that PPA has been in