4-5% drugs substandard, need concerted effort and stern action: DCGI

PHARMACEUTICAL SECTOR

THREE TO five per cent of the drugs in the Indian market are still substandard and the central drug regulator and state regulators would require to put in “concerted effort” and take “stern actions” to deal with it, stated G N Singh, Drug Controller General of India (DCGI), in his letter to all state drug regulators on December 30.

"Although the menace of spurious drugs has reduced over the years, the percentage of Not of Standard Quality drugs reported in the country are still hovering around 4-5 per cent...therefore, I solicit your sincere cooperation for making a concerted effort to reduce to a great extent the occurrence of substandard and spurious drugs even if it requires stern actions" G N Singh noted.

India has 36 drug regulators. There is one central drug regulator which is known as Central Drugs Standard Control Organization (CDSCO) — DCGI is its head — and the remaining 35 are drug regulators of various states and Union territories. Each of them keep testing the drugs on various quality parameters.

"Issues related to quality/safety of drugs and pharmaceuticals manufactured, distributed and consumed require to be resolved as a whole. Drugs comprise of a major portion of health budget and we cannot compromise on the quality of our health service owing to the questionable standards of quality and safety of drugs which may otherwise lead to failure in our health programmes, wasteful expenses and loss of income and productivity," Singh mentioned in his letter.

According to a November 28 report of The Indian Express, in a major crackdown since March this year, the drug regulators of seven states found that 27 medicines — sold by 18 major drug companies in India — were of ‘substandard’ quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.

Of the 18 companies, only two said they had stopped sale of the affected drug batches and just one said the affected batch had been recalled. The tests on the 27 medicines were done by regulators of Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra.

Wishing the state regulators a happy new year, Singh stated in his letter: "As we have the prime objective to ensure the safety, quality and efficacy of drugs, we cannot lag behind in such issues and cannot hurt the expectations of our society and global community."

Understanding the seriousness of the situation, the government is currently planning to amend the Drug and Cosmetics Rules, 1945, in order to create an effective recall system for the drugs that are found to be substandard by any drug regulator in the country. At present, neither there is a nation-wide drug recall system in the country nor are there any rules mandating the companies to withdraw ‘substandard’ drug batches from the market.