It might be difficult to implement compulsory prescription of generics

The enforcement by the drug regulator will not be easy given the shortage of drug inspectors

Prime Minister Narendra Modi wants to defeat the doctor-pharmaceutical company nexus and make medicines affordable by making it compulsory to prescribe drugs in the generic name.

But, the good intentions may not give the desired results. The enforcement will not be easy given the shortage of drug inspectors.

At an industry event at Surat last month, Modi announced plans for a new law to make generic prescriptions mandatory. Parallelly the government is already initiating steps to push for generic prescriptions. In a recent communication to all the states, the Centre has asked states to make sure all physicians write generic names of drugs in a legible manner. Business Standard has reviewed the letter.

The government has issued a draft amendment which will make it mandatory for companies to print generic names of the drug in a bolder font than the brand name on the packaging.

But, the government will face a difficult task in enforcing its decisions. Food and Drug Administration offices across the country are short staffed. There are 1800 inspectors and more than 25000 pharmaceutical companies in the country. The inspectors are tasked with inspecting facilities, ensuring companies comply with good manufacturing and distribution norms. They also regulate pharmaceutical distribution business and ensure that only trained pharmacists dispense drugs. Once these generic prescription rules come into force regulators will have to oversee its enforcement.

"Lakhs of prescriptions are written every day and how will these be checked. It will not be practical to implement generic only prescriptions," said S V Veeramani, ex-president of Indian Drug Manufacturers Association.

D G Shah, secretary general of Indian Pharmaceutical Alliance fears that the directive could lead to errors in prescribing and dispensing medicines as some molecule names sound similar. "Patient may end up getting the wrong medicine. The compulsory generic prescription is not a solution. Companies are not allowed to give gifts to doctors or give them commissions but there is no bar on giving commissions to chemists. The doctor-company nexus will be replaced by chemist-company nexus," Shah said.

In September 2016, Medical Council of India issued a notification to all doctors to prescribe generic drugs. It reiterated its directive after the prime minister's announcement. With these orders, doctors feel that the government will now have to keep an eye on pharmacists a lot more. Doctors and the pharmaceutical Industry fear that pharmacists will start operating on margins, thus prescribe medicines that will fetch him a higher margin on sales. At present, the pharmacist cannot substitute one medicine for another without the consent of the doctor. In the absence of a brand name, the pharmacist can dispense medicine any brand.

Across the country, it has been found that complaints of pharmacists flouting sales norms are a lot more than companies marketing spurious drugs. Tamil Nadu, for instance, 460 cases have been registered by the state FDA against chemists for not having qualified pharmacists to sell drugs. As compared to this, the number of cases against pharmaceutical companies marketing sub-standard drugs have been sold is minuscule. A senior official from the Tamil Nadu Food and Drug Administration (TNFDA) told Business Standard, "A lot of pharmacies don't have qualified pharmacists to dispense medicines. Unauthorised personnel are found giving patients medicines." State regulators have the powers to first issue a warning to these pharmacies for violating norms. If the offence is repeated the concerned FDA can suspense the pharmacist's license.

Meanwhile, companies have already found a loophole in the medical council's order. Companies are asking their medical representatives to inform doctors that they can prescribe brand names along with the generic name of the medicine. They state that while the Medical Council of India order states that generic name must be prescribed, doctors are not prohibited from writing the brand name of the medicine. Aristo Pharmaceuticals, the fifth largest player in the Asthma Segment as per IMS health, in a letter to its sales representatives states, " The MCI and Health Ministry expect doctors to write generic names of drugs prescribed but there are no pure generic products in the market. The generics available are only with brand names and are not exactly generics." Business Standard has reviewed a copy the letter.

Over 90 per cent of the Indian pharmaceutical industry is of branded generics and only 10 per cent is unbranded generics. Unbranded generic medicines are sold only in public health centres and government-owned pharmacies like the Jan Aushadhi Stores.