Unconditional free import of 6 - APA
DGFT has allowed unconditional free import of 6-APA. Hitherto there was a condition that “imports are permitted subject to Registration and other requirements as administered by Drug Controller General of India under the provisions of Drugs and Cosmetics Act.”. This condition is now deleted.
6-APA finds a place in the Customs Tariff against SH 2941 10 50 under Antibiotics - Penicillins and their derivative with a penicillanic acid structure; salts thereof.
APA stands for Amino Penicillanic Acid; the molecular formula is C8H12N2O3S. It is used for the production of semisyntheticpenicillins.The first 6-APA plant was established in India by IDPL in 1981 in technical collaboration with Farmfin, Italy.
Ampicillin was first discovered in 1961. However it was only in 1965, the first commercial process was developed. Penicillin, the first antibiotic, was discovered in 1929. In 1940, a commercial process for its manufacture was developed. Its shortcomings, like its narrow range of spectrum, resistance developed pathogenic bacteria, allergic side reactions, soon became apparent. 6-APA, the central molecule of penicillin was first isolated in 1950. It was in 1959 that a viable process for its manufacture was developed. It was also discovered that by substituting the side chain of penicillin by amino group, its effectiveness against gram negative bacteria is substantially enhanced. It was then, that ampicillin was discovered. Later on more such semi synthetic Penicillins, like amoxycillin, have been discovered. In 1965 the first commercial process, using Dane's Salt, was established. Initially the efficiencies were low. In 1973 the acid chloride process was established. Soluble enzymes were used for the manufacture of 6-APA. Efficiency was low and the production cost was high. Later, a chemical process was developed. It was sturdier and more efficient. However, it required handling of many hazardous chemicals.
DGFT NOTIFICATION No.36,(RE-2006)/2004-2009, Dated: November 21, 2006