The pharma companies operating in the state are increasingly realizing the need to become quality conscious. More and more firms who are into production or manufacturing of formulations and APIs are currently in the process of upgrading their facilities according to WHO GMP requirements.
M Venkata Reddy, director of Drug Control Administration says that about 60-70 per cent of the major pharma units in the state are GMP compliant. A technically sound team of regulatory officials is at service offering guidance to pharmaceutical units who look for assistance.
Commending on the measures taken by AP DCA with regard to increasing awareness among manufacturers on issues such as GMP, GLP, GSP and Schedule M compliance, he said that DCA has regularly been in touch with manufacturers on these matters and had offered counseling, clarified doubts and given necessary advice. DCA and IPA have, in the past, conducted several seminars to educate the manufacturers on GMP, he added.
According to him, most of the small companies have already started renovating their facilities realising that companies will have no other option but close down if they don't comply international standards.
In another step to simplify the regulatory procedures and to make them more consumer oriented, the DCA has started 'citizen charters' where details of files under processing are provided, and the department has been able to clear the files much before the deadline. DCA has the distinction of awarding blood bank licenses within four days, Reddy informed.
However, certain section of the industry, on the other hand, was not so optimistic on the regulatory compliance scenario in the state. “I strongly believe that there is still a long way to go. It would be impractical to say that majority of pharma companies are aware of regulatory requirements and make efforts to comply the same. Leaving aside the leading 15-20 companies, rest of the companies in the state are far from complying to any of the regulatory or quality standards,” comments a highly placed source.
He said that the issue of Schedule M where pharma companies extended the deadline to 2004 by lobbying is a clear indicator that companies, particularly the smaller ones are not that regulatory savvy. ``Out of about 150 companies that bid for government tenders for supply of drugs to government, only two companies turn out to have WHO GMP approvals and the remaining get disqualified. About 80 per cent of the small pharma companies don't comply with FDA regulations, WHO GMP standards,'' he said.
Having the regulatory system in place itself is not the solution but following and implementing would only make the difference. Maintenance of air handling facilities, for instance, has been made necessary. But only a handful of companies take these issues seriously. In India we have rules everywhere, but we don't have followers, he added.
Cracking the whip against fake drugs
The AP Drugs Control Administration has organized several raids during the last one year, throughout the state and has seized crores of rupees worth spurious drugs, ayurvedic drugs containing allopathic drugs like sildenafil citrate, hospital drugs, physician samples etc., from several manufacturers, dealers, quacks, hospitals and unlicenced premises. As of now, spurious drugs in the state account for below 0.3 per cent, according to official figures.
M Venkata Reddy, director, DCA, AP said that the department has highest number of prosecutions in India. At present there are 900 under trial cases in various courts. More than 80 per cent of the prosecutions launched by DCA ended in conviction, and in several cases imprisonment ranged from three months to five years. They had detected and seized stocks of 9 spurious drugs during the year 2003, seized 13 ayurvedic drugs and found fakes of sildenafil citrate manufactured by 8 different firms.
Some of the steps state DCA is pushing with the trade are- advising to act against inflow of spurious drugs and 'not of standard quality' products. All druggists and chemists are instructed to deal only with the known authorized dealers, to make receipts and payments only through Demand Drafts or Cheques, receive goods only through proper transportation mode, where proofs such as bills can be provided. For products of not of standard quality, DCA has warned the retailers that they will be made responsible and accountable for possession of any such product with them when proved that the products were kept in spite of having full knowledge of their under quality.