Staff shortage at regulator to stand in way of generic drugs push

Branded generics occupies 90% of the Rs 1-lakh cr pharma market in India

To break the nexus between pharmaceutical companies and doctors pushing expensive medicines, Prime Minister Narendra Modi had said last month the government would put in place a legal framework to ensure doctors prescribe generic names of drugs, instead of brands.
 
Recently, the Centre had asked states to make sure physicians write the generic names of drugs in a legible way. Business Standard has reviewed the letter.
 
The government had issued a draft amendment to make it mandatory for companies to carry the generic names on packs in a font bolder than the brand name.
 

But enforcing the decision might hit a hurdle as the Food and Drug Administration (FDA) offices across the country are short-staffed.

 
There are 1,800 inspectors and more than 25,000 pharmaceutical companies in the country. The officers are tasked with the responsibility of ensuring companies comply with manufacturing and distribution practices and inspect pharmaceutical distribution business. Once this generic prescription rules are enforced, regulators will have to oversee its proper implementation.
 
"Lakhs of prescriptions are written every day. How will these be checked? It won't be a practical decision to implement generic-only prescriptions," said S V Veeramani, former president of Indian Drug Manufacturers Association.
 
D G Shah, secretary-general of Indian Pharmaceutical Alliance, said the directive could lead to errors in prescribing and dispensing medicines, as some molecule names sound similar.

 
"Patients may end up getting the wrong medicine. Compulsory generic prescription is not a solution. Companies are not allowed to give gifts to doctors or commissions but there is no bar on giving commissions to chemists. The doctor-company nexus will be replaced by a chemist-company one," Shah added.
 
In September 2016, the Medical Council of India had issued a notification to all doctors to prescribe generic drugs. It reiterated its directive after the Prime Minister's announcement. This, doctors said, would make the government monitor pharmacists a lot more. Doctors and the pharmaceutical industry said pharmacists would start operating on margins. They might prescribe medicines that fetch a higher margin on sales. At present, a pharmacist cannot substitute one medicine with another without the consent of the doctor. In the absence of a brand name in prescriptions, the pharmacist can sell medicines of any brand.

 
There are more complaints of pharmacists flouting sales norms than companies marketing spurious drugs. In Tamil Nadu, in 2016, the state Food and Drug Administration (FDA) has registered 460 cases against chemists for not having qualified pharmacists to sell drugs compared with a mere 50 cases where pharmaceutical companies marketed sub-standard drugs.
 
"A lot of pharmacies don't have qualified pharmacists to dispense medicines. Unauthorised personnel are found giving medicines to patients," a senior official of the Tamil Nadu FDA told Business Standard. State regulators have powers to first issue a warning to these pharmacies for violating norms. If the offence is repeated, the FDA concerned can suspense the offender's licence.

 
Meanwhile, companies have already found a loophole in the medical council's order. They are asking their medical representatives to inform doctors that they can prescribe brand names along with the generic names.
 
While prescription of generic names is a must, doctors are not prohibited from writing a brand name of the medicine, they argued.
 
Aristo Pharmaceuticals, the fifth-largest player in the asthma segment, according to IMS health, in a letter to its sales representatives said, "The Medical Council of India and the health ministry expect doctors to write generic names of drugs 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 of the letter.
 
Branded generics occupies 90 per cent share of the ~1-lakh-crore pharma market in India, while the rest is taken up by the unbranded generics. Unbranded generic medicines are sold only in public health centres and government-owned pharmacies like the Jan Aushadhi Stores.