The laws that need to change to make prescription of generics compulsory

The government’s plan to make prescription of generics compulsory has left the pharmaceutical industry and the medical fraternity jittery. However, to ensure that generics are prescribed, the government needs to do more than just amend the existing rules in the Drug and Cosmetics Act, 1940. Implementation of the law will continue to be the biggest challenge going forward, say legal experts.

In October 2016, the Medical Council of India (MCI) amended rules to make it mandatory for doctors to prescribe generic names of drugs in prescriptions. However, the lacuna in respect to its enforceability remained as no action was taken by the council against doctors who did not follow the advisory, noted Radhika Pereria, partner, Shardul Amarchand Mangaldas.

The government could have regulated prescription practices by making the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) compulsory. Currently, it is voluntary on the part of the manufacturers to follow the guidelines. UCPMP was first floated in 2015 as a voluntary code with plans to make it mandatory after six months. But the code has remained voluntary, receiving four extensions since then. The latest extension came in September 2016 making it voluntary for an indefinite period.

The government recently floated a change in the drugs and cosmetic rules asking pharmaceutical companies to write the generic names of drugs in bold letters. It proposes to make it mandatory for pharma companies to carry generic names of a medicine in a font at least two sizes larger than the brand name.

The legal head of an Indian multinational pharma company is of the view that the government will have to bring about changes in licensing norms for chemists in the country to make the move for prescription of generics effective.

“India will have to introduce a norm that requires all chemists to offer the consumer all possible choices with each generic name,” he said. This amendment would be necessary to protect the consumer from being influenced by chemists while purchasing medicine, he added.

Legal experts fear the practice of prescribing generics could also lead to development of a cartel-like situation between chemists and drug distributors. Many are in favour of bringing in rules under the Drugs and Cosmetics Act to regulate chemists and drug distributors. There are around 800,000 chemists in the country. Currently, chemists are not covered under the Drugs and Cosmetics Act.

Some medical practitioners feel that if the government were to make prescription of generics compulsory, it should also ensure that prices of these drugs are uniform in each category. If that were to be so, the government would need to make further amendments in the existing legal and regulatory framework.