The government is going 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.
According to a senior government official, the revised rules may make it mandatory for the pharma companies to voluntarily recall any such drug, which is found to be substandard, from the supply chain in the market. 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.
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India has 36 drug regulators. There is one central drug regulator which is known as Central Drugs Standard Control Organization (CDSCO) and the remaining 35 are drug regulators of various states and Union territories. Each of the 36 regulators continuously keep testing the drugs, manufactured and sold in the country, on various quality parameters.
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.
While the regulators have been testing the drugs, the government is likely to make a rule wherein the firms would be creating a system for post-market surveillance — the firms would be drawing the samples from their supply chain to perform quality tests. If a firm finds a drug as substandard, it would have to voluntarily recall the whole batch from the market.
“Moreover, if the companies find any manufacturing defect or any flaw in its internal quality control system, then the affected drug batches would have to be recalled voluntarily. The revised rules may have this provision,” the government official added.
A sub-committee formed by the Drug Consultative Committee (DCC) has been asked to form the revised recall guidelines and submit its draft version to the health ministry. DCC is chaired by the chairman of CDSCO. The sub-committee, which consists of three members, has been asked by the DCC to take the opinion of state drug regulators too.
The government is moving in this direction as there is no effective drug recall system in India as of now. The Parliamentary Standing Committee, in its 2012 report on the functioning of CDSCO, said: “By the time a sample is tested, a large number of packs get sold with undeterminable injury to patients. There is no effective method of recalling unsold stocks (of substandard drugs) lying in the distribution network. This cannot be allowed to go on.”
The 2012 report added: “The Committee feels that there should be severe punishment for manufacturing and for allowing sub-standard drugs to enter the distribution chain. By amending rules, products with severe deficiencies should be penalised the same way as producers of spurious drugs. There is also a case to incorporate penal provisions for manufacturing misbranded and adulterated drugs.”
The Parliamentary Standing Committee also recommended that once a batch of a drug is found to be sub-standard and reported to CDSCO, the company selling that drugs should issue a press release and even insert paid advertisements in the newspapers apart from uploading the information on the CDSCO website. “Retail chemists should then be advised to stop selling unsold stocks and return the same to local drugs inspectors as per rules,” the committee said.
_______________________THE INDIAN EXPRESS_______________________
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