The SME Pharma Industries Confederation (SPIC) has urged the government to amend Section 124 of Drugs & Cosmetics Act for adopting United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) as official documents.

There are several drugs in the USP and BP which are not included in the Indian Pharmacopoeia (IP). Hence they are considered new drugs in India, forcing the companies to approach DCGI office for marketing permission. Moreover, for several drugs, procedures are simpler in the USP and BP than that of IP.

The SPIC made this demand, among a host others, in its executive meeting held on August 2 to chalk out action plan on key issues.

"Amendment of Section 124 of Drugs & Cosmetics Act may be effected to include BP and USP which should be made Official Pharmacopoeia for manufacturing in line with Second Schedule to the D&C Act (Standards of Drugs for Patent and Proprietary medicines)," SPIC said.

Under the Second Schedule to the D&C Act (Standards of Drugs for Patent and Proprietary medicines), USP is accepted for testing, but not for manufacturing. If it is extended for manufacturing also, several new drugs can be cut down from the IP and the manufacturers do not want to go to DCGI office for permission, SPIC secretary general Jagdeep Singh said.

Reiterating its commitment of providing quality medicines at affordable prices to common people, SPIC said that only SMEs supported Jan Aushadhi initiative of government. Lack of sufficient outlets and exclusively sourcing from PSUs has thwarted the initiative. Sourcing from SMEs could have minimized their dependence on MNC job work for survival. The meeting also resolved to support government efforts in eradication of spurious drugs.

In its demand, SPIC also said that the Common Logo Scheme for quality and affordability as suggested by SPIC should be implemented to provide medicines at Jan Aushadhi prices all over the country. Prices of medicines can easily be reduced to half with the scheme.

Schedule M was notified in 2001 and implemented in 2005 but no funds have been provided to SMEs to implement it till date. Grants/low cost loans should be provided to SMEs for Schedule M compliance if India has to have the capacity to provide affordable drugs and also counter the Chinese threat and also become an export hub. Parliament Subordinate legislation Committee's 181st report needs to be followed wherein a serious view has been taken of closure of SSI owing to Schedule M, SPIC demanded in its executive committee meeting.