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The government has done well to make the implementation of Good Manufacturing Practices (GMP) mandatory for drug producers in the country. GMPs, which were revised and brought on par with World Health Organisation (WHO) standards in 2018, are mostly observed in the breach by companies in India, including some big drug manufacturers. A time-bound implementation schedule has now been prescribed for them. Companies with a turnover of over Rs 250 crore will have to implement the revised GMPs within six months.
Medium and small-scale enterprises have been given a one-year deadline. Union Health Minister Mansukh Mandaviya has said that those who do not comply with the direction will face suspension of licence and/or penalty. The order has come in the wake of reports that a Madhya Pradesh-based pharma firm has been told to halt the manufacturing of its cough syrup which has been linked to the deaths of some children in Cameroon.
Pharma companies based in other states have also been held responsible for deaths in countries like the Gambia and Uzbekistan in the past. These cases have dented the credibility of Indian pharma companies and brought disrepute to the country which is often described as the ‘pharmacy of the world’.
A recent inspection of some drug units and testing labs had found many deficiencies like the absence of testing of raw materials before use, of investigation of product quality failures, and faulty design of manufacturing and testing areas. Only about 2,000 of the 10,500 manufacturing units were found to be compliant with the global WHO-GMP standards. The implementation of the WHO standards will lead to many changes in the manufacturing process, including introduction of validation of equipment and implementation of quality protocols at different stages of production and distribution.
While the prescription is good, the challenge may lie in administering the medicine to the pharma companies. Even now companies exporting medicines to other countries have to be WHO-GMP certified, but the series of incidents and complaints about poor quality from other countries show that many of them have not implemented the standards so far. Similarly, there are requirements under the Drugs and Cosmetics Act to be followed by companies producing drugs for the domestic market. These are also not followed correctly and sincerely. The gaps in the regulatory mechanism will have to be plugged and the rules enforced strictly for the best results. There will be demands to stretch the time schedule for implementation of the norms. There may also be attempts to evade implementation in other ways. The government must ensure that the standards are implemented in total and without compromise.